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This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies
The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter Dermatomyositis/Polymyositis(DM/PM) or Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Inhibitors of janus kinase including tofacitinib 5 mg once a day or twice a day and baricitinib 2mg once a day or 4mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate inhibitors of janus kinase's clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tofacitinib or baricitinib | Experimental | Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib | Drug | Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Responses | Changes of follicular helper T cells (TFH) before and after tofacitinib treatment are analysed to evaluate efficacy. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Myositis Disease Activity Assessment Tool(MDAAT) | Change of MDAAT(Myositis Disease Activity Assessment Tool) is measurement of effectiveness. MDAAT ranges from 0 to 10cm. The more severe the disease activity, the higher the score. We define response as an improvement of MDAAT at least 5%. | week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Any subject meeting either of the following criteria should be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Xing | Contact | +86 18518732225 | 1119745376@qq.com | |
| Jing He | Contact | +86 18611707347 | hejing1105@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li | Peking University Institute of Rheuamotology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39873740 | Derived | Xing X, Li Y, Liu Q, Wang N, Zhang K, Mo W, Zhao L, Zhang J, Ma K, Zhao X, Lu D, He J. Tofacitinib treatment for active dermatomyositis and anti-synthetase syndrome: a prospective cohort pilot study. Rheumatology (Oxford). 2025 Jun 1;64(6):3756-3766. doi: 10.1093/rheumatology/keaf046. |
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| ID | Term |
|---|---|
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| C000596027 | baricitinib |
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