CTRI/2024/05/067540
Recruiting
Phase 2
A randomized controlled trial to compare the efficacy of Tofacitinib with mycophenolate mofetil in patients with Systemic Sclerosis -interstitial Lung disease - INSIST-II
Post Graduate Institute of Medical Education and Research Chandigarh0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: M340- Progressive systemic sclerosis
- Sponsor
- Post Graduate Institute of Medical Education and Research Chandigarh
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study recruits individuals aged 18\-60, diagnosed with Systemic Sclerosis (SSc) or related disorders, having SSc for \=10 years and an FVC of 40\-80%. Participants must show HRCT evidence of ILD and have previously received, but not recently, immunosuppressants like cyclophosphamide or rituximab. They should be on maintenance immunosuppression and exhibit progressive lung function decline.
Exclusion Criteria
- •Exclusion criteria include recent tobacco use, significant chest X\-ray or HRCT abnormalities besides ILD, recent immunosuppression with MMF or cyclophosphamide, prednisolone \= 10 mg/day, persistent leukopenia or thrombocytopenia, pregnancy, severe pulmonary hypertension, major airflow obstruction, planned major surgery, active infection, myositis, serious comorbidities, allergies to study drugs, hepatitis B/C positivity, high serum creatinine or liver enzymes, and a history of thrombotic events.
Outcomes
Primary Outcomes
Not specified
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