Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) • ClinicalTrials.gov ID: NCT05785065
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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.
Interventions
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Mycophenolate Mofetil
(Drug)
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
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Placebo
(Other)
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
Eligibility criteria
Conditions
Locations
- 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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