Status:
UNKNOWN
Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies
Lead Sponsor:
Peking University People's Hospital
Conditions:
Idiopathic Inflammatory Myopathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies
Detailed Description
The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter Dermatomyositis/Polymyosit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05400889
Start Date
June 10 2022
End Date
June 1 2023
Last Update
October 12 2022
Active Locations (1)
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1
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China