Health Condition 1: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: TOFACITINIB: TOFACITINIB will be given at
dose of 5 mg twice a day for 48
weeks
Control Intervention1: Mycophenolate Mofetil: MMF will be started at a dose of
500 mg bd and uptitrated t
Sponsors
Post Graduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion 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 40-85%. 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in forced vital capacity (FVC) (%) in subjects with systemic sclerosis- Interstitial lung disease(SSc-ILD) when treated with Tofacitinib or mycophenolate mofetilTimepoint: at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)change in modified Rodnan score 2)Absolute change from baseline in FVC in liters 3)change in 6-minute walking distance. 4)to compare the change in quality of scores byMedical outcomes short form(SF-36) and dyspnea scores by Mahler Dyspnea index.5)all-cause mortality.6)incidence of adverse effects between two groups.Timepoint: at 24 and 48 weeks | — |
Countries
India
Contacts
Public ContactDr Susheel Thakur
Post Graduate Institute of Medical education and Research, Chandigarh
Outcome results
None listed