Health Condition 1: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: Tacrolimus: Tacrolimus will be given at dose of 1-4 mg/day in 2 divided doses to maintain a trough level of 5-10 ng/ml
Control Intervention1: Mycophenolate Mofetil: MMF will be started
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. 1. Age 18-75 years 2. Patients with SSc as diagnosed by the American College of Rheumatology (ACR) criteria, 2013 and patients with other connective tissue diseases who, in parallel, meet the ACR criteria for SSc (overlap syndromes except inflammatory myopathy) 3. Duration of SSc for ââ?°Â¤7 years, with onset defined as the appearance of the first non-Raynaudââ?¬•s symptom 4. Consenting for participating in study 5. FVC - 40-80% 6. DLco- 30-80% of normal 7. HRCT chest suggestive of ILD ( >10% of lung parenchyma) 8. May have received immunosuppression CYC (ââ?°Â¥6 doses of IV or oral for 6 months) or MMF (ââ?°Â¥6months) previously but at least >6 months prior to randomization, and still have progressive declining lung function indicated by change of 10% in FVC and 15% in DLCO 9. On maintenance immunosuppression with azathioprine, low dose steroids (ââ?°Â¤10mg/day), but having progressive declining lung function
Exclusion criteria
Exclusion criteria: 1. FVC 2. DLco 3. Serum creatinine ââ?°Â¥1.2mg/dl 4. Smoking tobacco in last 6 months 5. Clinically significant abnormality on chest-x-ray other than ILD (e.g- lung mass, effusion) 6. Immunosuppression- MMF or cyclophosphamide in last 30 days 7. Prednisolone ââ?°Â¥10mg/day 8. Persistent leucopenia( 9. Pregnant or breastfeeding females 10. Severe pulmonary arterial hypertension (mean pulmonary arterial pressure >55mmHg) requiring drug therapy 11. Significant airflow obstruction (pre-bronchodilator FEV1/FVC ââ?°Â¤0.65%) 12. Known hypersensitivity to the trial medication or its components 13. Life expectancy of 14. Uncontrolled congestive heart failure 15. Uncontrolled hypertension 16. Major surgical procedures planned to occur during trial period 17. Any other abnormalities noted on chest X-ray or HRCT other than ILD 18. Active infection 19. Active myositis 20. Known seizure disorder 21. Other serious co-morbidities which could compromise the patientââ?¬•s ability to complete the study 22. Allergy/hypersensitivity to medication or its constituents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in forced vital capacity (FVC) (%) in subjects with SSc-ILD when treated with oral tacrolimus or mycophenolate mofetilTimepoint: At 24 weeks and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in FVC in mLTimepoint: At 24 weeks and 48 weeks;Absolute change from baseline in SGRQTimepoint: At 24 weeks and 48 weeks;All-cause mortalityTimepoint: At 24 weeks and 48 weeks;Change in 6-minute walking distance (Ã?â? 6MWD)Timepoint: At 24 weeks and 48 weeks;Change in mRSSTimepoint: At 24 weeks and 48 weeks;change in Quality of Life scores by Medical Outcomes Short Form 36 (SF-36) and dyspnea scores by Mahler Dyspnea IndexTimepoint: At 24 weeks and 48 weeks;Incidence of adverse effects between the two groupsTimepoint: At 24 weeks and 48 weeks;Treatment related mortalityTimepoint: At 24 weeks and 48 weeks | — |
Countries
India
Contacts
Public ContactDr Jithin Mathew
PGIMER
Outcome results
None listed