Randomized Double-Blind Placebo-Controlled Clinical Trial to Assess the Efficacy of Mycophenolate Mofetil in Subclinical Interstitial Lung Disease Associated With Systemic Sclerosis: a Feasibility Study
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.
• Able and willing to provide informed consent and adhere to study protocol;
• Women and men of all race/ethnicity, aged 18 years and older;
• SSc based on 2013 ACR-EULAR classification criteria;
• 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;
• Diagnosis of ILD within 7 years before screening;
• Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening;
• Able to communicate in French or English;