Health Condition 1: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: Tofacitinib: Tablet Tofacitinib 5mg twice daily oral for 6 months
Control Intervention1: Mycophenolate mofetil: Tablet Mycophenolate mofetil 500mg 2 tablets twice daily for 6months
Sponsors
Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in forced vital capacity (FVC) at six months 2. 6-minute walk test results Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of HRCT ChestTimepoint: 24 weeks;Change in Modified Medical Research Council (mMRC) Dyspnea ScoreTimepoint: 24 weeks;Change in Modified Rodnan Skin ScoreTimepoint: 24 weeks;Presence of Pulmonary HypertesnionTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactGeetabali Sircar
Institute of Postgraduate Medical Education and Research
Outcome results
None listed