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
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ClinicalTrials.gov Identifier: NCT02971683 |
Recruitment Status :
Recruiting
First Posted : November 23, 2016
Last Update Posted : January 30, 2019
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Condition or disease | Intervention/treatment | Phase |
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Polymyositis Dermatomyositis Autoimmune Necrotizing Myopathy Overlap Myositis Juvenile Myositis Above the Age of 18 | Drug: Abatacept subcutaneous Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM) |
Actual Study Start Date : | March 13, 2017 |
Estimated Primary Completion Date : | June 17, 2020 |
Estimated Study Completion Date : | June 18, 2021 |

Arm | Intervention/treatment |
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Active Comparator: Abatacept subcutaneous + Standard Treatment
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.
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Drug: Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days |
Placebo Comparator: Placebo of Abatacept subcutaneous + Standard Treatment
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.
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Drug: Placebo
Placebo of Abatacept subcutaneous |
- Number of subjects who achieve International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 [ Time Frame: At Week 24 ]
The IMACS DOI is:
- An improvement of ≥ 20% from baseline in 3 IMACS core measures AND
- No more than 2 IMACS core measure scores worsen by ≥ 25% from baseline, AND
- Manual Muscle Test (MMT-8) may not decrease by ≥ 25% from baseline
- Mean change from baseline to Week 24 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 24 ]
- Mean change from baseline to Week 24 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 24 ]
- Mean change from baseline to Week 24 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 24 ]
- Mean change from baseline to Week 24 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-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 biopsy) and 2 or more of the remaining 4 criteria.
ii) Subjects with a diagnosis of IIM other than DM include PM, autoimmune 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.
- Demonstrable muscle weakness measured by the MMT-8 of ≤ 135 units and any 3 of the following: i) MMT-8 ≤ 125 units; ii) Physician's global assessment (PGA) visual analog scale (VAS) ≥2 cm; iii) Subject's global assessment (SGA) VAS ≥2 cm; iv) HAQ-DI ≥ 0.5; v) One or more muscle enzyme (CK, aldolase, LDH, AST, ALT) ³ 1.3 times upper limit of normal (ULN); vi) MDAAT Extramuscular Global Activity VAS ≥2 cm
- Demonstration of currently active IIM will be determined by an adjudication committee unless the subject has any one of the following: i) an active myositis-associated rash (Gottron's papules or heliotrope rash), or ii) a recent (within 3 months prior to signing informed consent) biopsy, magnetic resonance imaging (MRI), or electromyogram (EMG) demonstrating active disease, or iii) an elevated CK > 5 times the upper limit of normal
- Active disease despite prior treatment with corticosteroids, immunosuppressants, or biologics as determined by the investigator
- The subject must be on background standard treatment for IIM. The standard treatments that are allowed as background treatment for IIM includes: i) Corticosteroids alone, or ii) One of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or iii) A combination of corticosteroids and one of the above immunosuppressants. The subject must have been on the same medication(s) for IIM for 12 weeks prior to randomization and the dose must have been stable for 4 weeks prior to randomization. If using azathioprine, the subject must have been on azathioprine for at least 24 weeks with a stable dose for at least 12 weeks prior to randomization.
Exclusion Criteria:
- Subjects with Inclusion Body Myositis (IBM), or myositis other than IIM, eg, drug-induced myositis and PM associated with HIV
- Subjects treated with penicillamine or zidovudine in the past 3 months
- Subjects treated with rituximab in the 6 months prior to randomization (there must be laboratory results indicating the presence of circulating B cells [CD19+]). Any other biologic treatment in the past 3 months or immune globulin (intravenous [IVIG] or subcutaneous [SCIG]) in the past 3 months prior to randomization
- Subjects with uncontrolled or rapidly progressive interstitial lung disease
- Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
- Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer
- Subjects who are known to be positive for the anti-TIF-1 (p155/140) autoantibody prior to randomization who were diagnosed with IIM < 1 year prior to randomization.
- Subjects at risk for tuberculosis
- Subjects with recent acute infection requiring antibiotics
- Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections
- Subjects who have a present malignancy or have had a previous malignancy within the last 5 years prior to screening (except for a documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).
Other protocol defined inclusion/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971683
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT # and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:




Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02971683 History of Changes |
Other Study ID Numbers: |
IM101-611 2016-002269-77 ( EudraCT Number ) |
First Posted: | November 23, 2016 Key Record Dates |
Last Update Posted: | January 30, 2019 |
Last Verified: | January 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Muscular Diseases Dermatomyositis Myositis Polymyositis Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |
Connective Tissue Diseases Skin Diseases Abatacept Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |