Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Interstitial Lung Disease
- Myositis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A 1:1 randomization scheme for abatacept 125 mg vs. placebo as a weekly subcutaneous (SQ) injection for 24 weeks.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Only the site pharmacist is unblinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a proof of concept study to evaluate the efficacy, safety and tolerability of abatacept in Syn-ILD in a multi-center randomized, placebo-controlled 6-month (24-week) pilot study.
This is a proof of concept study to evaluate the efficacy, safety and tolerability of abatacept in Syn-ILD in a multi-center randomized, placebo-controlled 6-month (24-week) pilot study.
Tracking Information
- NCT #
- NCT03215927
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Rohit Aggarwal, MD University of Pittsburgh
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