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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02896205
• Date of registration: 27/08/2016
• Prospective Registration: Yes
• Primary sponsor: Postgraduate Institute of Medical Education and Research
• Public title: Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease MYILD
• Scientific title: A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease
• Date of first enrolment: October 2016
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02896205
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: GSRSNK Naidu, MD
• Affiliation: Post Graduate Institute of Medical Education and Research

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Interstitial Lung Disease

Scleroderma

Systemic Sclerosis

Intervention(s)

Drug: Placebo

Drug: Mycophenolate mofetil

Primary Outcome(s)

Change from baseline in Forced vital capacity (FVC) at 6 months, after treatment with oral mycophenolate mofetil or placebo [Time Frame: 6 months]

Secondary Outcome(s)

Change from baseline in Quality of Life (QoL) score by Medical Outcome Short Form 36 (SF-36v2) at 6 months [Time Frame: 6 months]

Change from baseline in Mahler Dyspnoea Index (MDI) at 6 months [Time Frame: 6 months]

Number of participants with serious and non seroius adverse events with mycophenolate mofetil (MMF) and placebo [Time Frame: 6 months]

Change in Forced Vital Capacity (FVC) from baseline to 6 months according to antibody (anti-centromere and anti-topoisomerase1) profile [Time Frame: 6 months]

Secondary ID(s)

NK/2612/DM/10772

Source(s) of Monetary Support

Please refer to primary and secondary sponsors