Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with
dense, thick fibrous tissue. Normally, the immune system helps defend the body against
disease and infection. In people with scleroderma, the immune system triggers fibroblast
cells to produce too much of the protein collagen. The extra collagen becomes deposited in
the skin and organs, causing hardening and thickening that is similar to the scarring
process. Although scleroderma most often affects the skin, it also can affect other parts of
the body, including the lungs, and in its most severe forms scleroderma can be
life-threatening. Scleroderma-related interstitial lung disease is one example of a
life-threatening scleroderma condition. In people with symptomatic scleroderma-related
interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung
function. The purpose of this study is to determine whether people with symptomatic
scleroderma-related interstitial lung disease experience more respiratory benefits from
treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of
oral cyclophosphamide.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Roth Philip Clements
Collaborators:
Hoffmann-La Roche National Heart, Lung, and Blood Institute (NHLBI)