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Plan change: Plan to add a center
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This study aims to explore the clinical characteristics and mechanism of Deucravacitinib 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/Polymyositis(DM/PM) or Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Deucravacitinib 6 mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate Deucravacitinib 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib 6mg po qd | Drug | Deucravacitinib 6mg once a day for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| IMACS-defined improvement | The International Myositis Assessment and Clinical Studies (IMACS) definition of improvement (DOI) criteria require improvement of ≥20% in at least three of the six Core Symptom Metrics (CSMs), with no more than two CSMs showing a worsening of ≥25% (excluding MMT-8); | week 24 |
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Inclusion Criteria:
Adults between 18 years and 75 years of age.
Exclusion Criteria:
Any subject meeting either of the following criteria should be excluded:
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Clinical Rheumatologist
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23758833 | Background | Rayavarapu S, Coley W, Kinder TB, Nagaraju K. Idiopathic inflammatory myopathies: pathogenic mechanisms of muscle weakness. Skelet Muscle. 2013 Jun 7;3(1):13. doi: 10.1186/2044-5040-3-13. | |
| 28385805 | Background | Aggarwal R, Rider LG, Ruperto N, Bayat N, Erman B, Feldman BM, Oddis CV, Amato AA, Chinoy H, Cooper RG, Dastmalchi M, Fiorentino D, Isenberg D, Katz JD, Mammen A, de Visser M, Ytterberg SR, Lundberg IE, Chung L, Danko K, Garcia-De la Torre I, Song YW, Villa L, Rinaldi M, Rockette H, Lachenbruch PA, Miller FW, Vencovsky J; International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann Rheum Dis. 2017 May;76(5):792-801. doi: 10.1136/annrheumdis-2017-211400. |
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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 |
|---|---|
| C000628674 | deucravacitinib |
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| 38467779 | Background | Morand E, Merola JF, Tanaka Y, Gladman D, Fleischmann R. TYK2: an emerging therapeutic target in rheumatic disease. Nat Rev Rheumatol. 2024 Apr;20(4):232-240. doi: 10.1038/s41584-024-01093-w. Epub 2024 Mar 11. |
| 40642501 | Background | McNamara ME, Tjahjono L. Successful treatment of recalcitrant amyopathic dermatomyositis with deucravacitinib in addition to intravenous immunoglobulin. JAAD Case Rep. 2025 Mar 29;62:6-8. doi: 10.1016/j.jdcr.2025.01.047. eCollection 2025 Aug. No abstract available. |