Trial · NCT02971683
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
NCT02971683, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2021-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy. Trials, record NCT02971683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02971683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
- NCT number
- NCT02971683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18
- Interventions
- Abatacept subcutaneous, Placebo
- First posted
- 2016-11-23
- Last updated
- 2023-10-30
- Other registries' IDs
- eudract:2016-002269-77
- Results first posted
- 2021-09-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | From first dose to 24 weeks after first dose. (Approximately 169 days) | 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. |
| Secondary | Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | 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). |
| Secondary | Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | 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). |
| Secondary | Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | 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). |
| Secondary | Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | 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). |
| Secondary | Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period | 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) | 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. |
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period | 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) | 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. |
| Secondary | Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period | 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) | The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions. |
| Secondary | Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period | 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) | 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. |
| Secondary | Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period | From first dose up to approximately 56 days post last dose (up to approximately 54 months) | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | From first dose to 24 weeks after first dose. (Approximately 169 days) | All treated participants excluding participants with relevant protocol deviations | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | All treated participants with both baseline and post-baseline measurements | Score on a scale | MEAN |
| SECONDARY | Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | All treated participants with both baseline and post-baseline measurements | Number of repetitions | MEAN |
| SECONDARY | Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | All treated participants with both baseline and post-baseline measurements | Score on a scale | MEAN |
| SECONDARY | Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24 | From first dose to 24 weeks after first dose. (Approximately 169 days) | All treated participants with both baseline and post-baseline measurements | Score on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period | 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) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period | 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) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period | 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) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period | 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) | All treated participants with at least one laboratory result for each analyte | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period | From first dose up to approximately 56 days post last dose (up to approximately 54 months) | All participants who received at least one dose of abatacept. Participants are summarized under their actual Double-Blind treatment groups, but during the Open-Label and Long-Term Extension Periods all participants received abatacept. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | Abatacept + Standard Treatment | 42 | 44.8 to 67.2 | Participants | |
| Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | Placebo + Standard Treatment | 31 | 31.6 to 54.5 | Participants | |
| Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | Abatacept + Standard Treatment | -0.31 | Standard Error 0.067 | Score on a scale | |
| Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 | Placebo + Standard Treatment | -0.20 | Standard Error 0.069 | Score on a scale | |
| Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24 | Abatacept + Standard Treatment | 4.1 | Standard Error 1.33 | Number of repetitions | |
| Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24 | Placebo + Standard Treatment | 1.2 | Standard Error 1.38 | Number of repetitions | |
| Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24 | Abatacept + Standard Treatment | -1.56 | Standard Error 0.202 | Score on a scale | |
| Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24 | Placebo + Standard Treatment | -1.40 | Standard Error 0.208 | Score on a scale | |
| Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24 | Abatacept + Standard Treatment | 40.83 | Standard Error 2.873 | Score on a scale | |
| Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24 | Placebo + Standard Treatment | 37.22 | Standard Error 2.963 | Score on a scale |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (24 Weeks) | STARTED | Abatacept + Standard Treatment | 75 | |
| Double-Blind (24 Weeks) | STARTED | Placebo + Standard Treatment | 73 | |
| Double-Blind (24 Weeks) | COMPLETED | Abatacept + Standard Treatment | 69 | |
| Double-Blind (24 Weeks) | COMPLETED | Placebo + Standard Treatment | 65 | |
| Double-Blind (24 Weeks) | NOT COMPLETED | Abatacept + Standard Treatment | 6 | |
| Double-Blind (24 Weeks) | NOT COMPLETED | Placebo + Standard Treatment | 8 | |
| Open-Label | STARTED | Abatacept + Standard Treatment | 69 | |
| Open-Label | STARTED | Placebo + Standard Treatment | 63 | |
| Open-Label | COMPLETED | Abatacept + Standard Treatment | 65 | |
| Open-Label | COMPLETED | Placebo + Standard Treatment | 61 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | Abatacept + Standard Treatment | 3 | 138 | |
| other | Influenza | Infections and infestations | Placebo + Standard Treatment | 6 | 73 | |
| other | Nasopharyngitis | Infections and infestations | Abatacept + Standard Treatment | 9 | 138 | |
| other | Nasopharyngitis | Infections and infestations | Placebo + Standard Treatment | 8 | 73 | |
| other | Fall | Injury, poisoning and procedural complications | Abatacept + Standard Treatment | 4 | 138 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo + Standard Treatment | 4 | 73 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Abatacept + Standard Treatment | 7 | 138 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo + Standard Treatment | 2 | 73 | |
| other | Headache | Nervous system disorders | Abatacept + Standard Treatment | 8 | 138 | |
| other | Headache | Nervous system disorders | Placebo + Standard Treatment | 7 | 73 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept + Standard Treatment | 0 | 138 |
| Total, all-cause mortality | Placebo + Standard Treatment | 1 | 73 |
| Total, other adverse events | Abatacept + Standard Treatment | 31 | 138 |
| Total, other adverse events | Placebo + Standard Treatment | 23 | 73 |
| Total, serious adverse events | Abatacept + Standard Treatment | 22 | 138 |
| Total, serious adverse events | Placebo + Standard Treatment | 5 | 73 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: deaths from any cause | Trial comparisons |
| Abatacept + Standard Treatment vs Placebo + Standard Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02971683
GET https://conductscience.org/api/trials/v1/NCT02971683/results?page=2