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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Total number of potentially eligible patients identified per site
Timeframe: Over one year
Proportion of potentially eligible patients who provide consent per site
Timeframe: Over one year
Proportion of consented participants who meet the eligibility criteria per site
Timeframe: Over one year
Monthly rate of randomized participants per site
Timeframe: Over one year
Adherence to treatment as assessed by Participant Dosing Diaries
Timeframe: From the first dose to the last dose taken for each participant, up to 96 weeks
Drug adherence rate as assessed by Pharmacy Accountability Logs
Timeframe: From the first dose to the last dose taken for each participant, up to 96 weeks
Adherence to the study protocol as assessed by the number of protocol deviations
Timeframe: Over total study period (up to 96 weeks per participant)
Proportion of participants intolerant to the study drug who discontinue trial treatment
Timeframe: Over total study period (up to 96 weeks per participant)
Proportion of participants receiving the allocated treatment at 48 weeks
Timeframe: At 48 weeks
Proportion of participants receiving the allocated treatment at 96 weeks
Timeframe: At 96 weeks
Proportion of participants with complete primary efficacy outcome data at 48 weeks
Timeframe: At 48 weeks
Proportion of participants with complete primary efficacy outcome data at 96 weeks
Timeframe: At 96 weeks
Proportion of participants lost to follow-up
Timeframe: Over total study period (up to 96 weeks per participant)