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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 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Autoimmune Necrotizing Myopathy Overlap Myositis Juvenile Myositis Above the Age of 18 Drug: Abatacept subcutaneous Drug: Placebo Phase 3

Study Design

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 4, 2021


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Abatacept subcutaneous + Standard Treatment
Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
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 followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Drug: Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days
Drug: Placebo
Placebo of Abatacept subcutaneous


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean change from baseline to Week 12 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 12 ]
  2. Mean change from baseline to Week 24 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 24 ]
  3. Mean change from baseline to Week 12 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 12 ]
  4. 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 ]
  5. Mean change from baseline to Week 12 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 12 ]
  6. Mean change from baseline to Week 24 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 24 ]
  7. Mean change from baseline to Week 12 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 12 ]
  8. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) or a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody; ii) Subjects with IIM other than DM (PM, autoimmune necrotizing myopathy, myositis associated with other autoimmune connective diseases (overlap myositis), or juvenile myositis with age ≥ 18 years) must also have a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody

  • 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, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), ALT) ≥ 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 1 month 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.

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 past year or any other biologic treatment or Intravenous Immunoglobulin (IVIG) in the past 6 months.
  • 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
  • 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

Contacts and Locations

Information from the National Library of Medicine

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


Contacts
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 #.

  Show 86 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

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 17, 2018
Last Verified: January 2018

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