JPRN-jRCTs031220641
Recruiting
Phase 2
Exploratory Study to Evaluate the Efficacy and Safety of Baricitinib in Interstitial Pneumonia Associated with Anti-MDA5 Antibody-Positive Dermatomyositis
Fujio Keishi0 sites5 target enrollmentFebruary 16, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Interstitial pneumonia associated with anti-MDA5 antibody-positive dermatomyositis
- Sponsor
- Fujio Keishi
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Those who are positive for anti\-MDA5 antibody.
- •2\. Those who meet the definition of clinically amyopathic dermatomyositis (CADM) or classical DM proposed by Sontheimer.
- •3\. Those who have interstitial pneumonia on chest CT.
- •4\. Those who are between 18 and 75 years of age at the time consent is obtained.
- •5\. Gender is not required.
- •6\. Any immunosuppressive therapy prior to participation in this study is acceptable.
- •7\. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
- •8\. Those who can conduct inspections in accordance with the research implementation schedule.
Exclusion Criteria
- •1\. Those who have serious infection.
- •2\. Those who have active tuberculosis.
- •3\. Those who have a neutrophil count of less than 500 /mm3\.
- •4\. Pregnant women or those who may be pregnant.
- •5\. Those who are on dialysis or with severe renal insufficiency (eGFR\<30 mL/min/1\.73m2\).
- •6\. Those who have a lymphocyte count less than 200 /mm3\.
- •7\. Those who are positive for HBs antigen or HBV\-DNA
- •8\. Those who are undergoing treatment for malignancy or have a history of malignancy within 5 years.
- •9\. Those who are using a JAK inhibitor other than baricitinib.
- •10\. Those who have active thrombosis (within 30 days of onset).
Outcomes
Primary Outcomes
Not specified
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