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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 : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

November 21, 2016
November 23, 2016
March 7, 2018
March 13, 2017
June 17, 2020   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02971683 on ClinicalTrials.gov Archive Site
  • Mean change from baseline to Week 12 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 12 ]
  • 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 12 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 12 ]
  • 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 12 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 12 ]
  • 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 12 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 12 ]
  • 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 ]
  • Mean change from baseline to Week 12 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 12 ]
  • 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 52 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 52 ]
  • 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 ]
  • 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 52 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 52 ]
  • Mean change from baseline to Week 12 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 12 ]
  • 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 52 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 52 ]
  • 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 ]
  • 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 ]
  • Mean change from baseline to Week 52 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 52 ]
Not Provided
Not Provided
 
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
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)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Polymyositis
  • Dermatomyositis
  • Autoimmune Necrotizing Myopathy
  • Overlap Myositis
  • Juvenile Myositis Above the Age of 18
  • Drug: Abatacept subcutaneous
    Specified dose of Abatacept subcutaneous on specified days
  • Drug: Placebo
    Placebo of Abatacept subcutaneous
  • 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.
    Intervention: Drug: Abatacept subcutaneous
  • 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.
    Interventions:
    • Drug: Abatacept subcutaneous
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
June 4, 2021
June 17, 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
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 #.
Australia,   Brazil,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Sweden,   United States
 
 
NCT02971683
IM101-611
2016-002269-77 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP