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Immunomodulator

Abatacept subcutaneous + Standard Treatment for Overlap Myositis

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose in the long-term open label period up to 56 days post last dose in the long-term open label period (up to approximately 958 days)
Awards & highlights

Study Summary

This study is evaluating whether a drug called abatacept can help reduce muscle inflammation in people with inflammatory myopathy.

Eligible Conditions
  • Autoimmune Necrotizing Myopathy
  • Overlap Myositis
  • Juvenile Myositis
  • Dermatomyositis
  • Polymyositis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose in the long-term open label period up to 56 days post last dose in the long-term open label period (up to approximately 958 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose in the long-term open label period up to 56 days post last dose in the long-term open label period (up to approximately 958 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
Secondary outcome measures
Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Abatacept subcutaneous + Standard TreatmentActive Control1 Intervention
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.
Group II: Placebo of Abatacept subcutaneous + Standard TreatmentPlacebo Group1 Intervention
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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Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,129,915 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2017. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02971683.
~19 spots leftby Apr 2025
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