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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

NCT02971683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-10-30

Study results available
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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

Conditions

  • Polymyositis
  • Dermatomyositis
  • Autoimmune Necrotizing Myopathy
  • Overlap Myositis
  • Juvenile Myositis Above the Age of 18

Interventions

DRUG

Abatacept subcutaneous

Specified dose of Abatacept subcutaneous on specified days

DRUG

Placebo

Placebo of Abatacept subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2020-07-27
Completion
2022-08-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • South Korea
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02971683 on ClinicalTrials.gov