NCT02971683

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Abatacept subcutaneous	Specified dose of Abatacept subcutaneous on specified days
DRUG	Placebo	Placebo of Abatacept subcutaneous

Timeline

• Start date: 2017-05-04
• Primary completion: 2020-07-27
• Completion: 2022-08-02
• First posted: 2016-11-23
• Last updated: 2023-10-30
• Results posted: 2021-09-17

Locations

79 sites across 11 countries: United States, Australia, Brazil, Czechia, France, Germany, Italy, Japan, Mexico, South Korea, Sweden

Regulatory

• FDA-regulated drug study