A Phase 3 interventional study of Abatacept subcutaneous and Placebo in Polymyositis, Dermatomyositis and Autoimmune Necrotizing Myopathy, sponsored by Bristol-Myers Squibb. Completed at 79 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 149 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polymyositis. 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.
-Diagnosis of IIM based on the Bohan and Peter classification criteria: i) Subjects with dermatomyositis (DM) must also have a confirmed myositis-associated rash (Gottron's papules or a heliotrope rash preferably confirmed by skin ) and 2 or more of the remaining 4 criteria.
ii) Subjects with a diagnosis of IIM other than DM include PM, necrotizing myopathy, myositis in association with another connective tissue disease (overlap myositis) and juvenile myositis subjects above the age of 18. These subjects must have a prior muscle biopsy diagnostic for IIM or a positive test for at least one myositis-specific autoantibody (anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS), anti-Mi-2, anti-SRP, anti-TIF1-g, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR). For subjects with overlap myositis, the myositis must be the principal clinically active manifestation of their disease. Where applicable, documentation of prior skin biopsy, muscle biopsy, and autoantibody results must be obtained and retained by the site.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Drug: Abatacept subcutaneous
Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Drug: Placebo
Specified dose of Abatacept subcutaneous on specified days
Placebo of Abatacept subcutaneous
Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24. The IMACS DOI is: An improvement of \>/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline. IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
Time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).
Time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions. The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).
Time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24
The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments. The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).
Time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24
The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity. The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( \>/= 20 represents minimal improvement, a score of \>/= 40 represents moderate improvement, and a score of \>/= 60 represents major improvement).
Time frame: From first dose to 24 weeks after first dose. (Approximately 169 days)
Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
Time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
Time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.
Time frame: From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
Time frame: From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Cumulative Abatacept Period
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
Time frame: From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Number of Participants Experiencing Laboratory Test Abnormalities in the Open-Label Period
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported. For participants who enter the Japan open-label extension period or long-term extension period, assessments after the first dose in the open-label period and before the first dose date in the subsequent period are included. For participants who prematurely discontinue the open-label period or complete the open-label period but do not enter the Japan open-label extension period or long-term term extension period, assessments after the first dose in the open-label period and up to 56 days post last dose are included.
Time frame: From first dose in open label period to first dose date in the subsequent period or up to 56 days post last dose (up to approximately 666 days)
Number of Participants Experiencing Laboratory Test Abnormalities in the Long-Term Open Label Period
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported. For participants who completed/discontinued the Long-Term Extension Period, assessments after the first dose in the Long-Term Extension Period and up to 56 days post last dose in the Long-Term Extension Period are included.
Time frame: From first dose in the Long-Term Open Label Period up to 56 days post last dose in the Long-Term Open Label Period (up to approximately 958 days)
| Milestone | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Started | 75 | 73 |
| Completed | 69 | 65 |
| Not completed | 6 | 8 |
| Withdrew: Other reasons | 0 | 1 |
| Withdrew: Poor/non-compliance | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Participant withdrew consent | 1 | 1 |
| Withdrew: Participant request to discontinue study treatment | 1 | 1 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lack of efficacy | 2 | 2 |
| Withdrew: Participant no longer meets study criteria | 1 | 0 |
| Milestone | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Started | 69 | 63 |
| Completed | 65 | 61 |
| Not completed | 4 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Participants withdrew consent | 0 | 2 |
| Withdrew: Participant request to discontinue study treatment | 1 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Milestone | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Started | 25 | 21 |
| Completed | 1 | 0 |
| Not completed | 24 | 21 |
| Withdrew: Administrative reason by sponsor | 20 | 17 |
| Withdrew: Participant withdrew consent | 1 | 0 |
| Withdrew: Participant request to discontinue study treatment | 1 | 1 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Lack of efficacy | 1 | 1 |
The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24. The IMACS DOI is: An improvement of \>/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline. IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | 42 (44.8 to 67.2) | 31 (31.6 to 54.5) |
The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).
| Score on a scale | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | -0.31 ± 0.067 | -0.20 ± 0.069 |
The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions. The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).
| Number of repetitions | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24 | 4.1 ± 1.33 | 1.2 ± 1.38 |
The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments. The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).
| Score on a scale | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24 | -1.56 ± 0.202 | -1.40 ± 0.208 |
The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity. The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( \>/= 20 represents minimal improvement, a score of \>/= 40 represents moderate improvement, and a score of \>/= 60 represents major improvement).
| Score on a scale | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24 | 40.83 ± 2.873 | 37.22 ± 2.963 |
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period | 52 | 55 |
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period | 4 | 4 |
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Infections | 19 | 31 |
| Malignancies | 0 | 0 |
| Autoimmune Disorders | 2 | 3 |
| Systemic Injection Reactions | 4 | 5 |
| Local Injection Site Reactions | 1 | 0 |
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| LOW LEUKOCYTES | 1 | 0 |
| HIGH LEUKOCYTES | 2 | 4 |
| HIGH EOSINOPHILS (ABSOLUTE) | 3 | 2 |
| LOW LYMPHOCYTES (ABSOLUTE) | 17 | 14 |
| LOW NEUTROPHILS + BANDS (ABSOLUTE) | 1 | 0 |
| HIGH ALANINE AMINOTRANSFERASE (ALT) | 1 | 1 |
| HIGH ASPARTATE AMINOTRANSFERASE (AST) | 0 | 1 |
| HIGH G-GLUTAMYL TRANSFERASE (GGT) | 4 | 1 |
| HIGH BLOOD UREA NITROGEN | 0 | 1 |
| HIGH CREATININE | 3 | 3 |
| HIGH CALCIUM, TOTAL | 1 | 0 |
| LOW PHOSPHORUS, INORGANIC | 0 | 1 |
| HIGH PHOSPHORUS, INORGANIC | 1 | 0 |
| HIGH SODIUM, SERUM | 0 | 1 |
| LOW GLUCOSE, SERUM | 4 | 3 |
| HIGH GLUCOSE, SERUM | 8 | 8 |
| HIGH PROTEIN, TOTAL | 0 | 1 |
| HIGH CREATINE KINASE (CK) | 0 | 4 |
| HIGH LACTATE DEHYDROGENASE (LD) | 0 | 1 |
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period | 64 | 39 |
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period | 14 | 8 |
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Infections and infestations | 34 | 19 |
| Malignancies | 0 | 0 |
| Autoimmune Disorders | 5 | 4 |
| Systemic Injection Reactions | 5 | 3 |
| Local Injection Site Reactions | 2 | 2 |
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported. For participants who enter the Japan open-label extension period or long-term extension period, assessments after the first dose in the open-label period and before the first dose date in the subsequent period are included. For participants who prematurely discontinue the open-label period or complete the open-label period but do not enter the Japan open-label extension period or long-term term extension period, assessments after the first dose in the open-label period and up to 56 days post last dose are included.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| LOW HEMOGLOBIN | 0 | 1 |
| LOW LEUKOCYTES | 2 | 1 |
| HIGH LEUKOCYTES | 2 | 0 |
| HIGH EOSINOPHILS (ABSOLUTE) | 2 | 0 |
| LOW LYMPHOCYTES (ABSOLUTE) | 15 | 8 |
| HIGH LYMPHOCYTES (ABSOLUTE) | 1 | 0 |
| LOW NEUTROPHILS + BANDS (ABSOLUTE) | 2 | 0 |
| HIGH ALANINE AMINOTRANSFERASE (ALT) | 1 | 0 |
| HIGH ALKALINE PHOSPHATASE (ALP) | 0 | 2 |
| HIGH ASPARTATE AMINOTRANSFERASE (AST) | 0 | 1 |
| HIGH G-GLUTAMYL TRANSFERASE (GGT) | 2 | 1 |
| HIGH BLOOD UREA NITROGEN | 2 | 1 |
| HIGH CREATININE | 6 | 2 |
| HIGH POTASSIUM, SERUM | 1 | 0 |
| LOW GLUCOSE, SERUM | 1 | 1 |
| HIGH GLUCOSE, SERUM | 3 | 3 |
| LOW ALBUMIN | 0 | 1 |
| HIGH CREATINE KINASE (CK) | 3 | 5 |
| HIGH LACTATE DEHYDROGENASE (LD) | 0 | 1 |
| HIGH BLOOD, URINE | 2 | — |
| HIGH WBC, URINE | 1 | — |
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported. For participants who completed/discontinued the Long-Term Extension Period, assessments after the first dose in the Long-Term Extension Period and up to 56 days post last dose in the Long-Term Extension Period are included.
| Participants | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| LOW HEMOGLOBIN | 1 | 0 |
| LOW LYMPHOCYTES (ABSOLUTE) | 1 | 4 |
| HIGH BLOOD UREA NITROGEN | 2 | 0 |
| HIGH CREATININE | 2 | 1 |
| HIGH GLUCOSE, SERUM | 1 | 0 |
| HIGH CREATINE KINASE (CK) | 1 | 0 |
Collected over All-cause mortality was assessed from participants first dose to their study completion (up to approximately 55 months) SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 55 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abatacept + Standard Treatment | 0/138 (0%) | 22/138 (15.9%) | 31/138 (22.5%) |
| Placebo + Standard Treatment | 1/73 (1.4%) | 5/73 (6.8%) | 23/73 (31.5%) |
| Event | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| Urinary tract infectionInfections and infestations | 3/138 | 0/73 |
| Large intestine polypGastrointestinal disorders | 2/138 | 0/73 |
| CellulitisInfections and infestations | 2/138 | 0/73 |
| Spinal compression fractureInjury, poisoning and procedural complications | 2/138 | 0/73 |
| PolymyositisMusculoskeletal and connective tissue disorders | 2/138 | 1/73 |
| VomitingGastrointestinal disorders | 0/138 | 1/73 |
| Herpes zosterInfections and infestations | 1/138 | 1/73 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/138 | 1/73 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/138 | 1/73 |
| Coronary artery diseaseCardiac disorders | 1/138 | 0/73 |
| Event | Abatacept + Standard Treatment | Placebo + Standard Treatment |
|---|---|---|
| NasopharyngitisInfections and infestations | 9/138 | 8/73 |
| HeadacheNervous system disorders | 8/138 | 7/73 |
| InfluenzaInfections and infestations | 3/138 | 6/73 |
| FallInjury, poisoning and procedural complications | 4/138 | 4/73 |
| Back painMusculoskeletal and connective tissue disorders | 7/138 | 2/73 |
| HypertensionVascular disorders | 7/138 | 1/73 |
| Age, Continuous(Years) | Abatacept + Standard Treatment | Placebo + Standard Treatment | Total |
|---|---|---|---|
| Mean | 49.3 ± 14.41 | 48.1 ± 14.09 | 48.7 ± 14.22 |
| Age, Customized(Participants) | Abatacept + Standard Treatment | Placebo + Standard Treatment | Total |
|---|---|---|---|
| 16-29 years old | 9 | 9 | 18 |
| 30-39 years old | 8 | 14 | 22 |
| 40-49 years old | 14 | 14 | 28 |
| 50-59 years old | 31 | 19 | 50 |
| >/= 60 years old | 13 | 17 | 30 |
| Sex: Female, Male(Participants) | Abatacept + Standard Treatment | Placebo + Standard Treatment | Total |
|---|---|---|---|
| Female | 52 | 54 | 106 |
| Male | 23 | 19 | 42 |
| Ethnicity (NIH/OMB)(Participants) | Abatacept + Standard Treatment | Placebo + Standard Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 3 | 10 |
| Not Hispanic or Latino | 19 | 19 | 38 |
| Unknown or Not Reported | 49 | 51 | 100 |
| Race/Ethnicity, Customized(Participants) | Abatacept + Standard Treatment | Placebo + Standard Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 3 | 6 |
| Asian | 10 | 6 | 16 |
| Black or African American | 9 | 8 | 17 |
| White | 42 | 42 | 84 |
| Japanese | 11 | 10 | 21 |
| Other | 0 | 3 | 3 |
| Unknown | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2017 to primary completion in Jul 2020, 38 months.
Results were first posted in Sep 2021, 1 year 1 month after primary completion.
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