A Phase 2 interventional study of IL-1 Trap in Inflammation, Familial Mediterranean Fever and Still's Disease, Adult-Onset, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-04.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Phase 2, Interventional, and Treatment
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are associated with mutations in cryopyrin-encoding CIAS1.
This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation.
IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the treatment of rheumatoid arthritis and initial studies have shown activity against clinical and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit improved dosing convenience, potential for fewer injection site reactions, and improved efficacy due to the extremely high affinity of IL-1Trap for its target.
In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical, biochemical, and genetic correlates of inflammation will be measured at appropriate intervals to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible, based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects who complete the 1-year extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose until the study drug is commercially available.
Investigator comment:
This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014, with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol therefore still contains background and procedural information that refer to patients with FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already been completed and it has been decided to not enroll any more FMF patients because the number of subjects is too low to reach reasonable conclusions, in addition it has been difficult to recruit patients that are eligible. The background section and study procedures have largely been left as in the currently IRB approved protocol.
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in MEFV encoding Pyrin. NOMID, MWS and FCAS are associated with mutations in CIAS1-encoding cryopyrin.
This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation.
IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. Our result of the FCAS/MWS part of this study and a multi center phase III study in patients with FCAS/MWS provided the basis for the FDA approval of IL-Trap for the treatment of patients with the CAPS.
In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical, biochemical, and genetic correlates of inflammation will be measured at appropriate intervals to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible, based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects who complete the 1-year extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose.
Investigator comment:
This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014, with a new change in study sponsor, the NIH replacing Regeneron as sponsor. This protocol therefore still contains background and procedural information that refer to patients with FMF and FCAS/MWS and Still's disease, however only patients with Still's disease will be newly enrolled from this point on, enrollment for the FCAS/MWS patients has already been completed and it has been decided to not enroll any more FMF patients because the number of subjects is too low to reach reasonable conclusions, in addition it has been difficult to recruit patients that are eligible. Those Adults Still's patients, who complete the extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose. These individuals will have their medication supplied by the manufacturing company, Regeneron, until June 2010. At that time the subjects' health insurance companies will begin to pay for their medication supply or the subjects will begin treatment with Anakinra, another IL-1 blocker. Our follow-up plans for all patients who discontinue IL-1 Trap usage will be to monitor for any medication side effects or toxicities and collect adverse event data for 3 months post discontinuation. We will help our subjects to obtain insurance coverage for IL-1Trap.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 27 interventional studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Compared within Familial Mediterranean Fever, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or female subjects with inflammatory disease greater than or equal to 18 years of age.
Participation in NIH study number 94-AR-0105 ("Genetics and Pathophysiology of FMF and Related Disorders")
Subjects presenting with active NOMID, MWS, FCAS, FMF, or adult Still's disease based on clinical signs/symptoms and/or biochemical markers such as acute phase reactants (CRP, SAA or ESR). Subjects need not have both clinical features and biochemical markers of disease to be enrolled. However, both clinical and laboratory responses will be evaluated in each subject for improvement as outcome measures (even improvement of laboratory values found to be within the normal range at baseline).
Stable dose of , NSAIDs, DMARDs, or colchicine for four weeks prior to enrollment visit.
Females of (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at screening and a negative serum pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication.
Women of childbearing age and men able to father a child, who are sexually active, who agree to use a form of effective , including abstinence.
Negative PPD test using 5 T.U. intradermal testing per CDC guidelines, and no evidence of active TB on chest X-ray. Subjects with latent TB (positive PPD test) currently treated with adequate therapy initiated for at least one month prior to first dose of study medication may be included. Full prophylaxis regimens will be completed. Subjects who have been BCG-vaccinated will also be skin-tested.
Able to understand, and complete study-related questionnaires.
Able and willing to give and abide with the study procedures.
EXCLUSION CRITERIA:
Treatment with a during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study.
Current treatment with TNF inhibitors or recent discontinuation of TNF inhibitors (use within less than 5 half-lives of TNF inhibitor agent).
Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study.
Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB.
Positive test for or prior history of , or C.
History or concomitant diagnosis of congestive heart failure.
History of . Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled.
Known to CHO cell derived biologicals or any components of IL 1 Trap.
Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to autoinflammatory disease).
Presence of any of the following laboratory abnormalities at enrollment visit: creatinine greater than 1.5 times the , WBC less than 3.6 x 10(9)/mm(3); count less than 150,000 mm(3); or AST greater than 2.0 x ULN (ALT/AST greater than 2.0 x ULN in an adult Still's disease patient would prompt a hepatology consult prior to enrollment unless these abnormalities are considered by the Principal Investigator to be reflective of the underlying Still's disease).
Lactating females or pregnant females.
Subjects with asthma not adequately controlled on current therapy.
Enrollment in any other treatment study or use of an investigational agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer, since ending another investigational device or drug trial.
Subjects for whom there is concern about compliance with the protocol procedures.
Presence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IL-1 Trap
Mean Change in Daily Scores
Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 \[no symptom\] to 4 \[worst symptom\], with an overall range score of 0-12).
Time frame: 10 days for 4 patient, 6 days for 1 patient
Mean Change in ESR
ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time frame: 10 days for 4 patient, 6 days for 1 patient
Mean Change in hsCRP
hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time frame: 10 days for 4 patient, 6 days for 1 patient
Mean Change in SAA
SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation
Time frame: 10 days for 4 patient, 6 days for 1 patient
Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease
At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.
Time frame: 24 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 3 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 6 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 9 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 12 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 16 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 20 months
Mean Change in Patient's Global Assessment, by VAS
Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 24 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 3 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 6 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 9 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 12 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 16 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 20 months
Mean Change in Physician's Global Assessment, by VAS
Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 24 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 3 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 6 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 9 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 12 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 16 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 20 months
Mean Change in Patient's Assessment of Pain, by VAS
Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 24 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 3 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 6 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 9 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 12 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 16 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 20 months
Mean Change in Patient's Assessment of Fatigue, by VAS
Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 24 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 3 months
Mean Change in Tender Joint Count.
Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 6 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 9 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 12 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 16 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 20 months
Mean Change in Tender Joint Count
Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 24 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 3 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 6 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 9 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 12 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 16 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 20 months
Mean Change in Swollen Joint Count
Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 24 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 3 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 6 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 9 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 12 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 16 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 20 months
Mean Change in SF-36 Physical Component Score
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
Time frame: 24 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 3 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 6 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 9 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 12 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 16 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 20 months
Mean Change in SF-36 Mental Component Score
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
Time frame: 24 months
Mean Change in WBCs
White Blood Cell count change from baseline to 3 months
Time frame: 3 months
Mean Change in WBCs
White Blood Cell count change from baseline to 6 months
Time frame: 6 months
Mean Change in WBCs
White Blood Cell count change from baseline to 12 months
Time frame: 12 months
Mean Change in WBCs
White Blood Cell count change from baseline to 24 months
Time frame: 24 months
Mean Change in Ferritin
Ferritin level change from baseline to 3 months
Time frame: 3 months
Mean Change in Ferritin
Ferritin level change from baseline to 6 months
Time frame: 6 months
Mean Change in Ferritin
Ferritin level change from baseline to 12 months
Time frame: 12 months
Mean Change in Ferritin
Ferritin level change from baseline to 24 months
Time frame: 24 months
Mean Change in Serum Amyloid A
Time frame: 3 months
Mean Change in Serum Amyloid A
Time frame: 6 months
Mean Change in Serum Amyloid A
Time frame: 12 months
Mean Change in Serum Amyloid A
Time frame: 24 months
Mean Change in C-Reactive Protein
Time frame: 3 months
Mean Change in C-Reactive Protein
Time frame: 6 months
Mean Change in C-Reactive Protein
Time frame: 12 months
Mean Change in C-Reactive Protein
Time frame: 24 months
Mean Change in Erythrocyte Sedimentation Rate
Time frame: 3 months
Mean Change in Erythrocyte Sedimentation Rate
Time frame: 6 months
Mean Change in Erythrocyte Sedimentation Rate
Time frame: 12 months
Mean Change in Erythrocyte Sedimentation Rate
Time frame: 24 months
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects
Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 3 months
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects
Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 6 months
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects
Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 12 months
Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects
Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
Time frame: 24 months
Mean Change in Tender Joint Count in AOSD Subjects
Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 3 months
Mean Change in Tender Joint Count in AOSD Subjects
Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 6 months
Mean Change in Tender Joint Count in AOSD Subjects
Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 12 months
Mean Change in Tender Joint Count in AOSD Subjects
Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 24 months
Mean Change in Swollen Joint Count in AOSD Subjects
Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 3 months
Mean Change in Swollen Joint Count in AOSD Subjects
Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 6 months
Mean Change in Swollen Joint Count in AOSD Subjects
Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 12 months
Mean Change in Swollen Joint Count in AOSD Subjects
Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
Time frame: 24 months
Mean Change in Prednisone Dose
Time frame: 3 months
Mean Change in Prednisone Dose
Time frame: 6 months
Mean Change in Prednisone Dose
Time frame: 12 months
Mean Change in Prednisone Dose
Time frame: 24 months
| Milestone | IL-1 Trap |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 \[no symptom\] to 4 \[worst symptom\], with an overall range score of 0-12).
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Daily Scores | -3.09 ± 1.03 |
ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation
| mm/hour | IL-1 Trap |
|---|---|
| Mean Change in ESR | -32.2 ± 7.31 |
hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation
| mg/dl | IL-1 Trap |
|---|---|
| Mean Change in hsCRP | -4.22 ± 0.98 |
SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation
| mg/liter | IL-1 Trap |
|---|---|
| Mean Change in SAA | -216.1 ± 92.14 |
At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.
| participants | IL-1 Trap |
|---|---|
| Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease | 3 |
Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -5.29 ± 0.67 |
Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -2.56 ± 1.27 |
Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -2.63 ± 1.19 |
Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -2.86 ± 1.24 |
Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -3.40 ± 0.98 |
Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -2.78 ± 1.13 |
Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS | -2.33 ± 1.3 |
Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.15 ± 0.89 |
Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.27 ± 1.01 |
Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.71 ± 0.75 |
Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.30 ± 0.9 |
Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.85 ± 0.95 |
Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.79 ± 0.66 |
Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Physician's Global Assessment, by VAS | -4.54 ± 0.99 |
Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -5.43 ± 1.2 |
Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -4.24 ± 1.24 |
Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -3.93 ± 1.28 |
Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -3.08 ± 2.28 |
Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -5.65 ± 1.13 |
Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -5.01 ± 1.22 |
Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Pain, by VAS | -4.82 ± 1.22 |
Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -3.12 ± 1.04 |
Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -2.27 ± 1.15 |
Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -2.41 ± 1.1 |
Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -2.04 ± 1.17 |
Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -3.16 ± 0.67 |
Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -2.38 ± 0.89 |
Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Assessment of Fatigue, by VAS | -3.19 ± 1.63 |
Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -5.70 ± 3.49 |
Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count. | -4.30 ± 4.47 |
Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -4.80 ± 4.73 |
Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -7.40 ± 5.33 |
Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -9.60 ± 5.71 |
Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -8.40 ± 4.77 |
Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count | -6.80 ± 5.53 |
Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -7.90 ± 4.64 |
Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -2.50 ± 3.66 |
Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -2.30 ± 3.33 |
Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -6.10 ± 2.82 |
Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -9.00 ± 4.09 |
Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -9.40 ± 3.59 |
Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count | -4.20 ± 4.45 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 11.11 ± 3.74 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 13.09 ± 3.19 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 10.38 ± 4.45 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 13.28 ± 3.84 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 12.58 ± 3.23 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 10.12 ± 5.48 |
Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Physical Component Score | 10.22 ± 4.59 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 7.56 ± 4.97 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 5.95 ± 4.01 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 8.8 ± 4 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 9.76 ± 3.46 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 11.74 ± 6.42 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 12.98 ± 3.96 |
Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in SF-36 Mental Component Score | 11.46 ± 6.46 |
White Blood Cell count change from baseline to 3 months
| x 10^3 cells/microliter | IL-1 Trap |
|---|---|
| Mean Change in WBCs | 0.57 ± 1.17 |
White Blood Cell count change from baseline to 6 months
| x 10^3 cells/microliter | IL-1 Trap |
|---|---|
| Mean Change in WBCs | -1.29 ± 1.35 |
White Blood Cell count change from baseline to 12 months
| x 10^3 cells/microliter | IL-1 Trap |
|---|---|
| Mean Change in WBCs | -0.87 ± 1.08 |
White Blood Cell count change from baseline to 24 months
| x 10^3 cells/microliter | IL-1 Trap |
|---|---|
| Mean Change in WBCs | -2.88 ± 1.43 |
Ferritin level change from baseline to 3 months
| mcg/L | IL-1 Trap |
|---|---|
| Mean Change in Ferritin | -231.80 ± 138.11 |
Ferritin level change from baseline to 6 months
| mcg/L | IL-1 Trap |
|---|---|
| Mean Change in Ferritin | -184.80 ± 88.19 |
Ferritin level change from baseline to 12 months
| mcg/L | IL-1 Trap |
|---|---|
| Mean Change in Ferritin | 331.80 ± 575.34 |
Ferritin level change from baseline to 24 months
| mcg/L | IL-1 Trap |
|---|---|
| Mean Change in Ferritin | -263.80 ± 114.69 |
| mg/liter | IL-1 Trap |
|---|---|
| Mean Change in Serum Amyloid A | -117.80 ± 62.54 |
| mg/liter | IL-1 Trap |
|---|---|
| Mean Change in Serum Amyloid A | -173.40 ± 80.56 |
| mg/liter | IL-1 Trap |
|---|---|
| Mean Change in Serum Amyloid A | -274.20 ± 103.18 |
| mg/liter | IL-1 Trap |
|---|---|
| Mean Change in Serum Amyloid A | -173.25 ± 115.86 |
| mg/dl | IL-1 Trap |
|---|---|
| Mean Change in C-Reactive Protein | -4.79 ± 2.71 |
| mg/dl | IL-1 Trap |
|---|---|
| Mean Change in C-Reactive Protein | -5.67 ± 2.62 |
| mg/dl | IL-1 Trap |
|---|---|
| Mean Change in C-Reactive Protein | -7.06 ± 2.38 |
| mg/dl | IL-1 Trap |
|---|---|
| Mean Change in C-Reactive Protein | -4.91 ± 1.86 |
| mm/hour | IL-1 Trap |
|---|---|
| Mean Change in Erythrocyte Sedimentation Rate | -13.20 ± 10.85 |
| mm/hour | IL-1 Trap |
|---|---|
| Mean Change in Erythrocyte Sedimentation Rate | -32.40 ± 11.12 |
| mm/hour | IL-1 Trap |
|---|---|
| Mean Change in Erythrocyte Sedimentation Rate | -34.60 ± 14.26 |
| mm/hour | IL-1 Trap |
|---|---|
| Mean Change in Erythrocyte Sedimentation Rate | -23.40 ± 15.02 |
Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects | -0.16 ± 0.79 |
Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects | -0.75 ± 0.60 |
Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects | -0.97 ± 1.34 |
Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.
| units on a scale | IL-1 Trap |
|---|---|
| Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects | -1.03 ± 0.96 |
Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count in AOSD Subjects | 1.60 ± 2.98 |
Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count in AOSD Subjects | -2.00 ± 1.48 |
Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count in AOSD Subjects | -3.40 ± 3.06 |
Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| tender joints | IL-1 Trap |
|---|---|
| Mean Change in Tender Joint Count in AOSD Subjects | -6.80 ± 3.28 |
Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count in AOSD Subjects | 1.20 ± 3.89 |
Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count in AOSD Subjects | 0.60 ± 2.79 |
Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count in AOSD Subjects | -2.40 ± 2.60 |
Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)
| swollen joints | IL-1 Trap |
|---|---|
| Mean Change in Swollen Joint Count in AOSD Subjects | -2.60 ± 1.81 |
| mg/day | IL-1 Trap |
|---|---|
| Mean Change in Prednisone Dose | -0.50 ± 1.66 |
| mg/day | IL-1 Trap |
|---|---|
| Mean Change in Prednisone Dose | -1.50 ± 7.81 |
| mg/day | IL-1 Trap |
|---|---|
| Mean Change in Prednisone Dose | -4.10 ± 6.52 |
| mg/day | IL-1 Trap |
|---|---|
| Mean Change in Prednisone Dose | -7.00 ± 7.20 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IL-1 Trap | — | 5/11 (45.5%) | 11/11 (100%) |
| Event | IL-1 Trap |
|---|---|
| Renal CalculiRenal and urinary disorders | 2/11 |
| Blood and lymphatic system disorders - Other (Macrophage Activation Syndrome)Blood and lymphatic system disorders | 1/11 |
| Joint infection-mycobacteriumInfections and infestations | 1/11 |
| Skin Infection-mycobacteriumInfections and infestations | 1/11 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/11 |
| Cerebrospinal fluid leakageNervous system disorders | 1/11 |
| Kidney infectionRenal and urinary disorders | 1/11 |
| Event | IL-1 Trap |
|---|---|
| SinusitisInfections and infestations | 7/11 |
| upper respiratory infectionInfections and infestations | 6/11 |
| DiarrheaGastrointestinal disorders | 5/11 |
| Bronchial infectionInfections and infestations | 4/11 |
| Skin infectionInfections and infestations | 4/11 |
| HeadacheNervous system disorders | 4/11 |
| GastritisGastrointestinal disorders | 3/11 |
| Stomach painGastrointestinal disorders | 3/11 |
| PharyngitisInfections and infestations | 3/11 |
| Cholesterol highInvestigations | 3/11 |
| Age, Categorical(Participants) | IL-1 Trap |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | IL-1 Trap |
|---|---|
| Female | 4 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | IL-1 Trap |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | IL-1 Trap |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
The record gives a start of Oct 2004, a primary completion of Sep 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2013, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rilonacept
Familial Mediterranean Fever →
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) →