Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Treatment of Idiopathic Inflammatory Myopathies

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to explore the clinical characteristics and mechanism research of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• Adults between 18 years and 75 years of age.

• Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter DM/PM or American College of Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.

• Written informed consent should be obtained from each study subject.

• Concomitant immunosuppressive agents or glucocorticoids were allowed, but subjects should have been on these therapies at least 4 weeks and on a stable dose for ≥4 weeks(glucocorticoid doses are lower than <0.5mg/kg/d).

• Consent to use effective contraception during the study (women of childbearing age).

Exclusion Criteria:

Any subject meeting either of the following criteria should be excluded:

• Laboratory abnormality: Hb<8 g/dl or platelet<60*10^9/L, or combined with severe hepatic, renal and cardiac insufficiency;

• Myositis in overlap with another systemic autoimmune rheumatic disorder, cancer-associated myositis, inclusion body myositis or any other non-immune mediated myopathy.

• Biologics such as rituximab are not allowed in the 3-month before enrollment.

• Patients with malignancy within 3 years of screening.

• Patients with hypersensitivity to study drug.

• Active infections(including but not limited to hepatitis, HIV).

• Uncontrolled mental or emotional disorders.