Clinical Trial

RCT of Tocilizumab for Anti-MDA5+DM

Study acronym: PROMIS-MDA5
Recruiting
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Summary
The goal of this clinical trial is to learn if tocilizumab works to treat anti-MDA5+ dermatomyositis (anti-MDA5+DM) in adults. It will also learn about the safety of tocilizumab. The main questions it aims to answer are: Does tocilizumab improve patients' clinical symptoms? Does tocilizumab improve patients' respiratory failure? What medical problems do participants have when taking tocilizumab? Researchers will compare tocilizumab to a placebo (a look-alike substance that contains no drug) to see if tocilizumab works to treat patients with anti-MDA5+ DM. Participants will: Take tocilizumab or a placebo every two weeks for 2 months Visit the clinic once every 2 weeks for checkups and tests
Trial Details
NCT Number NCT07377058
Lead Sponsor Peking Union Medical College Hospital
Conditions Dermatomyositis
Enrollment 110 participants
Start Date 2025-11-01
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-29