Actively Recruiting
RCT of Tocilizumab for Anti-MDA5+DM
Led by Peking Union Medical College Hospital · Updated on 2026-01-29
110
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
RCT of Tocilizumab for Anti-MDA5+DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 65 years; no gender restriction; total body weight 45 kg or more
- Diagnosis of anti-MDA5 antibody-positive dermatomyositis with specific skin manifestations and positive serum anti-MDA5 antibodies
- If lung disease is present, oxygen saturation must be 90% or higher or PaO2 60 mmHg or higher
- Lung function with forced vital capacity percentage predicted (FVC%) 60% or higher and diffusion capacity (DLco%) 40% or higher
- Chest CT scan showing interstitial lung lesions involving less than 50% of lung fields
- Received oral prednisone (less than 1 mg/kg/day or equivalent) for at least 4 weeks before randomization
- Stable dose of calcineurin inhibitor (e.g., cyclosporine or tacrolimus) for at least 4 weeks before randomization; if immunosuppressives were stopped, a 4-week washout is required
- Prophylactic treatment with trimethoprim-sulfamethoxazole daily during treatment
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study
- Voluntary participation with signed informed consent
You will not qualify if you...
- Diagnosis of polymyositis, anti-synthetase syndrome, immune-mediated necrotizing myositis, or overlap myositis with other connective tissue diseases
- Life-threatening complications such as recent acute coronary syndrome or significant cerebrovascular disease
- Specific severe laboratory abnormalities including low white blood cells, neutrophils, lymphocytes, hemoglobin, or platelets
- Severe liver or kidney impairment based on lab values
- Hospitalization for severe infection within 60 days or recent intravenous antibiotic use without washout
- Untreated or inadequately treated active tuberculosis; latent tuberculosis must be treated with preventive therapy
- Active viral hepatitis or documented HIV infection
- Rapidly progressive interstitial lung disease within 4 weeks before screening
- Allergy to tocilizumab or its components
- Allergy to sulfonamide drugs
- Inability to complete pulmonary function testing at baseline
- Use of high-dose prednisone (over 2 mg/kg/day) prior to screening
- Recent use of intravenous immunoglobulin or certain immunosuppressive or biologic drugs within specified time frames
- Prior use of tocilizumab, other IL-6 inhibitors, or similar drugs
- Pregnant, breastfeeding, or planning pregnancy
- History of malignant tumors within the past 5 years except certain treated skin or cervical cancers
- Any other conditions considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
Hanqi Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here