Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD. Lung involvement is the most common cause of death in these patients. The present study is performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared with that of oral placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

1. Patients of systemic sclerosis with presence of interstitial lung disease on High Resolution Computer Tomography (HRCT) chest

2. FVC ≥ 70% of predicted on pulmonary function tests

3. Age ≥18 years

4. Consenting for participating in study

Exclusion Criteria:

1. Received immunosuppression (except low dose steroids, prednisolone equivalent ≤10 mg/day) for ILD in the last 3 years

2. Persistent leucopenia or thrombocytopenia

3. Pregnant or breastfeeding females

4. Severe pulmonary arterial hypertension (mean pulmonary arterial pressure >55mmHg) requiring drug therapy

5. Uncontrolled congestive heart failure

6. Any other abnormalities noted on chest X-ray or HRCT other than ILD

7. Active infection

8. Inflammatory myositis

9. Overlap syndrome

10. Mixed connective tissue disease

11. Other serious co-morbidities which could compromise patient's ability to complete the study