A study to compare two medicines for lung disease in scleroderma patients- Tacrolimus as compared to Mycophenolate Mofetil

Not Applicable

• Conditions: Health Condition 1: M340- Progressive systemic sclerosis

• Registration Number: CTRI/2021/11/037864
• Lead Sponsor: PGIMER Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 (�6 doses of IV or oral for 6 months) or MMF (�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 (�10mg/day), but having progressive declining lung function

Exclusion Criteria

1. FVC <40%

2. DLco <30%

3. Serum creatinine �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 �10mg/day

8. Persistent leucopenia( <4000/mm3) or thrombocytopenia ( <100,000/mm3)

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 �0.65%)

12. Known hypersensitivity to the trial medication or its components

13. Life expectancy of <3 years for disease other than the underlying CTD in investigator assessment

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (�� 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