A Phase 3 interventional study of anakinra and Placebo in Still's Disease, Adult-Onset and Still's Disease, Juvenile-Onset, sponsored by Swedish Orphan Biovitrum. Terminated at 39 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Swedish Orphan Biovitrum · Phase 3, Interventional, and Treatment
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The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).
The study consists of a 12-week, randomized, double-blind, placebo controlled period with two dose levels of anakinra and a 4-week safety follow-up after last dose of investigational medicinal product (IMP). The primary endpoint will be evaluated at Week 2. Sustained efficacy and time to study drug discontinuation will be evaluated during the full study period.
A screening visit is optional and may be done to identify patients that could be suitable for the study. During the study 6 visits and 2 telephone contacts are scheduled i.e., Day 1 (baseline visit), Day 4Tel, Week 1, Week 2, Week 4, Week 8, Week 12 and Week 16Tel (End of Study).
Patients will be randomly assigned to study drug, after they meet all of the inclusion criteria and none of the exclusion criteria. Patients will receive treatment for 12 weeks, either anakinra or placebo. Patients will be randomized to anakinra in a dose of either 2 or 4 mg/kg/day, with a maximum dose of 100 or 200 mg once daily, respectively. Patients will be randomized to placebo with corresponding volumes for each of the two anakinra dose levels.
23 studies on the registry are indexed under Still's Disease, Adult-Onset; 5 are open to participants now.
This study's enrollment of 13 is close to the median of 14 across 11 interventional studies indexed under Still's Disease, Adult-Onset.
Browse Still's Disease, Adult-Onset studies →Swedish Orphan Biovitrum is the lead sponsor of 82 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Use of the following therapies prior to randomization:
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
Biological: anakinra
Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
Drug: Placebo
sub cutaneous injection
Also known as: Kineret
sub cutaneous injection
Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L).
Time frame: Week 2
Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.
ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 1
Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.
ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 1
Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.
ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 1
Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.
ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 1
Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.
ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 2
Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.
ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 2
Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.
ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
Time frame: Week 2
Proportion of Responders in Physician Global Assessment of Disease Activity.
Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.
Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Responders in Number of Joints With Active Arthritis.
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Responders in Number of Joints With Limitation of Motion.
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).
Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Responders in CRP (mg/L).
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time frame: Week 2
Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.
Proportion of patients with absence of fever during the 7 days preceding Week 2.
Time frame: Week 2
Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.
Absence of fever during the 24 hours preceding week 1.
Time frame: Week 1
Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.
Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Time frame: Day 1 and Week 1
Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.
Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Time frame: Day 1 and Week 1
Change From Baseline in CRP.
Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
Time frame: Day 1 and Week 1
Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.
Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.
Time frame: Week 12
Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.
Time frame: Week 2, Week 4, Week 8 and Week 12
Proportion of Patients With Absence of Rash.
Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.
Time frame: Week 2
Change From Baseline in CRP.
Change from baseline in CRP. Results at Week 2 reported here.
Time frame: Week 2
Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.
Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
Time frame: Week 2
Change From Baseline in Platelet Count.
Change from baseline in platelet count. Results at Week 2 reported here.
Time frame: Week 2
Change From Baseline in Ferritin.
Change from baseline in ferritin. Results at Week 2 reported here.
Time frame: Week 2
Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.
Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
Time frame: Week 2
Time to Study Drug Discontinuation for Any Reason.
Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.
Time frame: From Day 1 to Week12
Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.
Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.
Time frame: From Day 1 to Week12
Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time frame: From Week 2 to Week12
Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time frame: From Week 2 to Week12
Percentage Decrease of the Glucocorticoid Dose From Baseline.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time frame: From Day 1 to Week12
Proportion of Patients With at Least One Adverse Event.
All adverse events collected from start of study treatment up to 28 days after stopping study treatment.
Time frame: From Day 1 to Week 16
Proportion of Patients With at Least One Serious Adverse Event Including Death.
Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.
Time frame: From Informed consent to Week 16
Proportion of Patients With Macrophage Activation Syndrome (MAS).
Proportion of patients with Macrophage Activation Syndrome (MAS).
Time frame: From Day 1 to Week 16
Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.
Proportion of patients with antidrug antibodies (ADA) against anakinra.
Time frame: Week 2
Proportion of Patients With Neutralizing Antibodies.
Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
Time frame: Week 2
Anakinra Serum Pre-dose Concentrations.
Week 2 reported here.
Time frame: Week 2
Anakinra Serum Pharmacokinetic Parameters: Cmax,
PK parameters only available for 2 patients.
Time frame: Week 12
Anakinra Serum Pharmacokinetic Parameters, Tmax and T½
PK parameters only available for 2 patients
Time frame: Week 12
Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h
PK parameters only available for 2 patients
Time frame: Week 12
Anakinra Serum Pharmacokinetic Parameter: CL/F
Pharmacokinetic parameters only available for 2 patients
Time frame: Week 12
Anakinra Serum Pharmacokinetic Parameter: Vd/F
PK parameters only available for 2 patients
Time frame: Week 12
Change From Baseline in JADAS27.
Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l are converted to 10 and CRP values \>110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57. Only results from Week 2 reported here.
Time frame: Week 2
Number of Days Off School or Work Due to Still's Disease.
Number of days off school or work due to Still's disease week 1-2.
Time frame: Week 2
Proportion of Patients With Inactive Disease.
Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.
Time frame: Week 12
Change From Baseline in IL-6.
Only results from Week 2 reported here.
Time frame: Week 2
Change From Baseline in IL-18.
Only results from Week 2 reported here
Time frame: Week 2
Change From Baseline in Serum Calprotectin.
Change from baseline in serum calprotectin. Only results from Week 2 reported here
Time frame: Week 2
Change From Baseline in Neopterin.
Only results from Week 2 reported here
Time frame: Week 2
| Milestone | Anakinra | Placebo |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 0 |
| Not completed | 0 | 6 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Progressive disease | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L).
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | 6 | 0 |
ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | 5 | 3 |
ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | 5 | 2 |
ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | 5 | 0 |
ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | 4 | 0 |
ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2. | 6 | 0 |
ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2. | 6 | 0 |
ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by \>30% from baseline.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2. | 5 | 0 |
Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in Physician Global Assessment of Disease Activity. | 4 | 0 |
Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being. | 4 | 0 |
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in Number of Joints With Active Arthritis. | 3 | 2 |
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in Number of Joints With Limitation of Motion. | 4 | 2 |
Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ). | 4 | 0 |
Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Responders in CRP (mg/L). | 5 | 0 |
Proportion of patients with absence of fever during the 7 days preceding Week 2.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2. | 6 | 0 |
Absence of fever during the 24 hours preceding week 1.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1. | 6 | 4 |
Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.
| mm | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Physician Global Assessment of Disease Activity at Week 1. | -46.3 ± 32.6 | -30.0 ± 18.5 |
Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.
| mm | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1. | -53.7 ± 27.7 | -25.0 ± 31.7 |
Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
| mg/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in CRP. | -109.6 ± 63.4 | -22.7 ± 47.1 |
Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response. | 6 | 0 |
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.
No measurements were reported for this outcome.
Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Absence of Rash. | 5 | 2 |
Change from baseline in CRP. Results at Week 2 reported here.
| mg/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in CRP. | -126.670 ± 66.697 | -33.904 ± 64.393 |
Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
| g/dL | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here. | 1.57 ± 0.86 | -0.80 ± 1.01 |
Change from baseline in platelet count. Results at Week 2 reported here.
| 10^9/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Platelet Count. | -148.2 ± 52.3 | -26.3 ± 139.6 |
Change from baseline in ferritin. Results at Week 2 reported here.
| ug/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Ferritin. | -390.364 ± 387.521 | -49.383 ± 51.776 |
Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
| score on a scale | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain. | -55.6 ± 27.7 | -33.5 ± 28.5 |
Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Time to Study Drug Discontinuation for Any Reason. | 0 | 5 |
Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.
| Participants | Anakinra | Placebo |
|---|---|---|
| Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease. | 0 | 4 |
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
No measurements were reported for this outcome.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
No measurements were reported for this outcome.
Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
No measurements were reported for this outcome.
All adverse events collected from start of study treatment up to 28 days after stopping study treatment.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With at Least One Adverse Event. | 6 | 4 |
Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With at Least One Serious Adverse Event Including Death. | 0 | 1 |
Proportion of patients with Macrophage Activation Syndrome (MAS).
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Macrophage Activation Syndrome (MAS). | 0 | 0 |
Proportion of patients with antidrug antibodies (ADA) against anakinra.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra. | 6 | 1 |
Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Neutralizing Antibodies. | 0 | 0 |
Week 2 reported here.
| ng/mL | Anakinra | Placebo |
|---|---|---|
| Anakinra Serum Pre-dose Concentrations. | 157 ± 134 | — |
PK parameters only available for 2 patients.
| ng/mL | Placebo | Anakinra |
|---|---|---|
| Anakinra Serum Pharmacokinetic Parameters: Cmax, | — | 1990.0 ± 1315.2 |
PK parameters only available for 2 patients
| hours | Placebo | Anakinra |
|---|---|---|
| Tmax | — | 3.06 ± 1.33 |
| T½ | — | 5.23 ± 1.01 |
PK parameters only available for 2 patients
| h*ng/mL | Placebo | Anakinra |
|---|---|---|
| Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h | — | 18483.3 ± 15708.4 |
Pharmacokinetic parameters only available for 2 patients
| mL/h*kg | Placebo | Anakinra |
|---|---|---|
| Anakinra Serum Pharmacokinetic Parameter: CL/F | — | 170.80 ± 45.69 |
PK parameters only available for 2 patients
| mL/kg | Placebo | Anakinra |
|---|---|---|
| Anakinra Serum Pharmacokinetic Parameter: Vd/F | — | 1254.52 ± 95.57 |
Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values \<10 mg/l are converted to 10 and CRP values \>110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57. Only results from Week 2 reported here.
| score on a scale | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in JADAS27. | -21.42 ± 3.93 | -15.81 ± 4.83 |
Number of days off school or work due to Still's disease week 1-2.
| Days | Anakinra | Placebo |
|---|---|---|
| Number of Days Off School or Work Due to Still's Disease. | 0.7 ± 1.6 | 1.3 ± 2.5 |
Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.
| Participants | Anakinra | Placebo |
|---|---|---|
| Proportion of Patients With Inactive Disease. | 3 | 0 |
Only results from Week 2 reported here.
| ng/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in IL-6. | -30.048 ± 23.262 | -24.818 ± 25.940 |
Only results from Week 2 reported here
| ng/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in IL-18. | -7968.0 ± 7564.4 | -20701.7 ± 32766.4 |
Change from baseline in serum calprotectin. Only results from Week 2 reported here
| mg/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Serum Calprotectin. | -100.038 ± 113.349 | -26.021 ± 23.819 |
Only results from Week 2 reported here
| nmol/L | Anakinra | Placebo |
|---|---|---|
| Change From Baseline in Neopterin. | -3.08 ± 5.69 | -8.00 ± 10.82 |
Collected over From the start of study treatment up to 28 days after stopping study treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anakinra | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Placebo | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) |
| Event | Anakinra | Placebo |
|---|---|---|
| Diffuse large B-cell lymphoma stage IIINeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/6 | 1/6 |
| Event | Anakinra | Placebo |
|---|---|---|
| Upper respiratory infectionInfections and infestations | 3/6 | 0/6 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 2/6 | 0/6 |
| VomitingGastrointestinal disorders | 2/6 | 0/6 |
| Injection site reactionGeneral disorders | 2/6 | 1/6 |
| Ear infectionInfections and infestations | 1/6 | 0/6 |
| Urinary tract infectionInfections and infestations | 0/6 | 1/6 |
| Viral upper respiratory tract infectionInfections and infestations | 1/6 | 0/6 |
| AnxietyPsychiatric disorders | 1/6 | 0/6 |
| DepressionPsychiatric disorders | 0/6 | 1/6 |
| DizzinessNervous system disorders | 1/6 | 1/6 |
| Age, Continuous(years) | Placebo | Anakinra | Total |
|---|---|---|---|
| Mean | 14.4 ± 13.2 | 12.3 ± 19.3 | 13.3 ± 16.0 |
| Sex: Female, Male(Participants) | Placebo | Anakinra | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 4 | 6 |
| Race (NIH/OMB)(Participants) | Placebo | Anakinra | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Anakinra | Total |
|---|---|---|---|
| United States | 5 | 6 | 11 |
| Still's disease symptom duration(Days) | Placebo | Anakinra | Total |
|---|---|---|---|
| Mean | 32.4 ± 18.7 | 109.0 ± 78.0 | 74.2 ± 69.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Feb 2019, 16 months.
Results were first posted in Apr 2020, 1 year 2 months after primary completion.
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Studies of the drug tested here: Interleukin 1 Receptor Antagonist Protein
Still's Disease, Adult-Onset →