A study to compare two medicines for lung disease in scleroderma patients- Tofacitinib ascompared to Mycophenolate Mofetil
- Conditions
- Health Condition 1: M340- Progressive systemic sclerosis
- Registration Number
- CTRI/2024/05/067540
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in forced vital capacity <br/ ><br>(FVC) (%) in subjects with <br/ ><br>systemic sclerosis- Interstitial lung <br/ ><br>disease(SSc-ILD) when treated with Tofacitinib <br/ ><br>or mycophenolate mofetilTimepoint: at 24 weeks
- Secondary Outcome Measures
Name Time Method 1)change in modified Rodnan score 2)Absolute <br/ ><br>change from baseline in FVC in liters 3)change <br/ ><br>in 6-minute walking distance. 4)to compare the <br/ ><br>change in quality of scores byMedical outcomes <br/ ><br>short form(SF-36) and dyspnea scores by <br/ ><br>Mahler Dyspnea index.5)all-cause <br/ ><br>mortality.6)incidence of adverse effects between <br/ ><br>two groups.Timepoint: at 24 and 48 weeks