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Effect of Tacrolimus on dermatomyositis/polymyositis

A Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028143
Enrollment
Unknown
Registered
2019-12-13
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dermatomyositis/polymyositis

Interventions

Treatment group:Glucocorticoid+Tacrolimus
Control group:Glucocorticoid+Cyclophosphamide

Sponsors

Department of Rheumatology and Immunology, Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects must meet the IIM and/or ADM diagnostic criteria; 2. between 18 and 75 years of age 3. Agree to use effective contraception during the study period (women of child-bearing age); 4. The patient voluntarily participate in the experiment with good compliance, and be able to understand and sign the informed consent before the study; 5. First diagnosis and initial treatment; 6. No immunosuppressive agents or not have received them for >=4 weeks prior to first dose of agent.

Exclusion criteria

Exclusion criteria: 1. merging other rheumatic diseases; 2. merging other diseases that may cause muscle lesions and symptoms of muscle weakness; 3. cancer history; 4. For patients with severe disorders of heart, liver, kidney and other important organs, as well as blood and endocrine system lesions; 5. Those who have received treatment with biological agents within 3 months; 6. Those who are in the period of acute or chronic infection or have a previous history of active tuberculosis; 7. Positive for hepatitis b surface antigen or hepatitis c antibody; 8. Allergy to the test drug or its components; 9. Patients with mental illness or other reasons who cannot cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
MDAAT;

Secondary

MeasureTime frame
MDI;chest HRCT;

Countries

China

Contacts

Public ContactWei Wei

Department of Rheumatology and Immunology, Tianjin Medical University General Hospital

tjweiwei2003@163.com+86 022 60361025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026