Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies
NCT ID: NCT05400889
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2022-06-10
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tofacitinib or baricitinib
Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
tofacitinib
Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
Interventions
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tofacitinib
Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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HeJing
Professor
Principal Investigators
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Zhanguo Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Rheuamotology and Immunology
Locations
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Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20220420 JAKi-IIM
Identifier Type: -
Identifier Source: org_study_id
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