Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies
Real-world Experience With Inhibitors of Janus Kinase for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study
1 other identifier
interventional
10
1 country
1
Brief Summary
This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Start
First participant enrolled
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 12, 2022
October 1, 2022
9 months
May 16, 2022
October 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Immunological Responses
Changes of follicular helper T cells (TFH) before and after tofacitinib treatment are analysed to evaluate efficacy.
week 24
Secondary Outcomes (1)
Myositis Disease Activity Assessment Tool(MDAAT)
week 24
Study Arms (1)
tofacitinib or baricitinib
EXPERIMENTALTofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
Interventions
Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li
Peking University Institute of Rheuamotology and Immunology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 16, 2022
First Posted
June 2, 2022
Study Start
June 10, 2022
Primary Completion
March 1, 2023
Study Completion
June 1, 2023
Last Updated
October 12, 2022
Record last verified: 2022-10