An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis
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|ClinicalTrials.gov Identifier: NCT04946669|
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : July 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dermatomyositis Abatacept||Drug: Abatacept||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
Experimental: Refractory Dermatomyositis
Patients who have been receiving glucocorticoids in combination with at least one immunosuppressive therapy for at least 3 months and who have failed therapy or are intolerant to therapy
Abatacept is a CTLA-4 fusion protein that inhibits T cell activation by competitively binding to CD80/CD86 and blocking the second signal. To date, Abatacept has been approved by the FDA for the treatment of three types of rheumatoid immune diseases (refractory rheumatoid arthritis, juvenile idiopathic arthritis, and active psoriatic arthritis). The international consensus of experts recommends abacepil as a second-line regimen for the treatment of refractory dermatomyositis based on the evidence of case reports. However, to date, there is no relevant report or clinical study registration information of Abatacept in the treatment of dermatomyositis.
- IMACS score improved [ Time Frame: 12 weeks after treat with Abatacept ]
Improvement of 3 core parameters of disease activity in the core assessment index of IMACS over 20 percent with no more than 2 parameters deteriorating over 25 percent.
And parameters of IMACS include Physician Global Assessment, Patient Global Assessment, Muscle strength assessment with MMT-8, Sports Ability Assessment Questionnaire, laboratory evaluation including creatine kinase, aldolase, lactic dehydrogenase and so on, Evaluation of myositis disease activity using MDAAT and appraisal of life quality.
- Dose of glucocorticoids used [ Time Frame: 12 weeks after treat with Abatacept ]Dose of glucocorticoids used
- Occurrence of adverse events [ Time Frame: 12 weeks after treat with Abatacept ]Occurrence of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04946669