An open-label study of tofacitinib versus mycophenolate mofetil in patients with systemic sclerosis
Phase 3
- Conditions
- Health Condition 1: M340- Progressive systemic sclerosis
- Registration Number
- CTRI/2022/09/046093
- Lead Sponsor
- Institute of Postgraduate Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method