Mycophenolate Mofetil for Systemic Sclerosis with Interstitial Lung Disease
(SSc-mILD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect lung disease, such as mycophenolate mofetil, azathioprine, and some others, before joining. If you're on any of these, you may need to stop them before participating.
Is Mycophenolate Mofetil safe for humans?
Mycophenolate Mofetil (also known as Cellcept or Myfortic) has been studied for safety in people with systemic sclerosis-related interstitial lung disease, and adverse events (unwanted effects) occurred at similar rates in both the treatment and placebo groups, suggesting it is generally safe for humans.12345
How does the drug Mycophenolate Mofetil differ from other treatments for systemic sclerosis-related interstitial lung disease?
Mycophenolate Mofetil (MMF) is unique because it is considered safer and better tolerated than cyclophosphamide, another drug used for this condition, and it may provide longer-lasting improvements. Unlike cyclophosphamide, which can have significant toxicity, MMF offers a more favorable safety profile for long-term use.12456
What data supports the effectiveness of the drug Mycophenolate Mofetil for treating systemic sclerosis with interstitial lung disease?
Who Is on the Research Team?
Sabrina Hoa, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with systemic sclerosis and mild lung involvement, diagnosed within the last 7 years. Participants must have a stable lung function and be able to consent and follow the study plan. They can't join if they've had worsening lung fibrosis in the past year, are on certain other medications, pregnant or not using contraception, have blood disorders or liver issues, heart failure, active infections or cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either mycophenolate mofetil or placebo for 96 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mycophenolate Mofetil
- Placebo
Mycophenolate Mofetil is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborator
McGill University
Collaborator
University of Calgary
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Sclérodermie Québec
Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Jewish General Hospital
Collaborator