CTRI/2022/09/046093Not yet recruitingPhase 3
A randomized, controlled, open label trial of tofacitinib versus mycophenolate mofetil in diffuse systemic sclerosis
Institute of Postgraduate Medical Education and Research0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •a. Patients of diffuse systemic sclerosis, fulfilling the ACR classification criteria for diagnosis, will be enrolled in the study.
- •b. Patients will be positive for anti Scl-70
- •c. Patients have ILD by HRCT criteria, or pulmonary function testing, or both.
Exclusion Criteria
- •a. Patients who have received tofacitinib or mycophenolate and other immunosuppressant in the last 3 months
- •b. Patients with pregnancy or breast-feeding
- •c. Patients with active systemic infections.
- •d. Patients with hepatitis B and C, HIV infections, tuberculosis and overlap syndromes
- •e. Patients with severe pulmonary hypertension (NYHA class IV)
- •f. Patient who had the history of thrombosis in the past.
Investigators
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