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Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-08-29
Completion Date
2028-12
Last Updated
2025-04-11
Healthy Volunteers
No
Interventions
Mycophenolate Mofetil
The participant will receive 500 mg to 1000 mg twice daily of mycophenolate mofetil administered orally for 96 weeks. The dose scheduling will be as follow: Weeks 1 and 2: 500 mg twice a day Weeks 3 and 4: 750 mg twice a day Weeks 5 to 96: 1000 mg twice a day
Placebo
The participant will receive 500 mg to 1000 mg twice daily of placebo administered orally for 96 weeks. The dose scheduling will be as follow: Weeks 1 and 2: 500 mg twice a day Weeks 3 and 4: 750 mg twice a day Weeks 5 to 96: 1000 mg twice a day
Locations (3)
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital - CIUSSS-COMTL
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et Pneumologie de Québec
Québec, Quebec, Canada