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Earlier Use of Mycophenolate Mofetil in Scleroderma: Clinical Trial
Scleroderma-Lung-Disease_PLS_Feature-Image
Scientific Study 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 Study Start and End Date: August 2024-December 2027
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Marie Hudson- Website Headshot-400x400
Marie Hudson
Research Scientist, Rheumatology MD, MPH, FRCPC

Why do this research?

Reason For Research

Scleroderma (or systemic sclerosis) is a rare but life-threatening disease in which the immune system attacks its own tissues. Scleroderma affects over 10,000 individuals in Canada and has the highest mortality rate out of all systemic autoimmune rheumatic diseases. The leading cause of death is lung disease, which affects over 50% of individuals with scleroderma. Currently, treatments to calm the immune system (immunosuppressive drugs, such as mycophenolate) are only given when lung disease is progressive or severe enough to cause symptoms or functional impairment. Unfortunately, treatments do not reverse the loss of lung function once it has occurred. Recent research suggests we may achieve better results if immunosuppressive drugs were started before lung damage occurs.

What will be done?

Execution of Research

We plan to conduct a pilot study to determine how best to conduct a clinical trial on the early use of mycophenolate in mild forms of scleroderma lung disease. We want to determine if earlier intervention is effective in preserving lung function. This trial has the potential to improve quality of life for people with scleroderma lung disease and prevent severe lung disease.

How Can People Get Involved?

Involvement

Study sites will include the Centre hospitalier de l’Université de Montréal (Montreal), the Jewish General Hospital (Montreal) and the Institut Universitaire de Cardiologie et de Pneumologie de Québec (Quebec City).

How are Equity, Diversity and Inclusion addressed or taken into consideration?

The study will recruit adults with scleroderma lung disease of all sex/gender and race/ethnicity.

Subgroup analyses will be performed to examine the effect of sex and ethnicity on study results.

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