Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University People's Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Active disease: MDAAT skin VAS ≥ 3 cm, with at least 3 core indicators abnormal;
Inadequate response to or intolerance of conventional treatments (such as glucocorticoids, immunosuppressants).
Disqualifiers
Combined with other systemic autoimmune diseases;
Severe hepatic and renal dysfunction;
Active infections (such as tuberculosis, hepatitis B, HIV);
Pregnant or lactating women;
Trial population
Clinical Rheumatologist
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deucravacitinib 6mg po qd
DrugDeucravacitinib 6mg once a day for 6 months.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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);
Time frame
week 24Sponsors and contacts
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Source ClinicalTrials.gov