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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 : Active, not recruiting
First Posted : November 23, 2016
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE November 23, 2016
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE March 13, 2017
Actual Primary Completion Date July 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Polymyositis
  • Dermatomyositis
  • Autoimmune Necrotizing Myopathy
  • Overlap Myositis
  • Juvenile Myositis Above the Age of 18
Intervention  ICMJE
  • Drug: Abatacept subcutaneous
    Specified dose of Abatacept subcutaneous on specified days
  • Drug: Placebo
    Placebo of Abatacept subcutaneous
Study Arms  ICMJE
  • 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.
    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 a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 18, 2021
Actual Primary Completion Date July 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Czechia,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Mexico,   Sweden,   United States
Removed Location Countries Hungary
 
Administrative Information
NCT Number  ICMJE NCT02971683
Other Study ID Numbers  ICMJE IM101-611
2016-002269-77 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

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