Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Trial Parameters
Brief Summary
The goal of this pilot study is to assess the feasibility of a larger study on the efficacy of mycophenolate mofetil in people diagnosed with systemic sclerosis with mild lung involvement. Participants will be recruited over 12 months at 3 academic centers and assigned randomly to receive either mycophenolate mofetil or placebo, a look-alike substance that contains no active drug, for 96 weeks.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide informed consent and adhere to study protocol; 2. Women and men of all race/ethnicity, aged 18 years and older; 3. SSc based on 2013 ACR-EULAR classification criteria; 4. Presence of interstitial lung disease on HRCT scan, obtained within 12 months before screening, that shows fibrosis affecting less than 20% of the lungs, as confirmed by an expert radiologist; 5. Diagnosis of ILD within 7 years before screening; 6. Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening; 7. Able to communicate in French or English; Exclusion Criteria: 1. Progressive pulmonary fibrosis, defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation, as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline; 2. Use of medications with putative lung disease-modify