NCT00883129 — drugset

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.

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	2 mg/kg	Oral
Subject	Mycophenolate Mofetil	Small molecule	1.5 g	Oral

Evaluation

Drug

Modality

Dose

Route

Subject

Cyclophosphamide

Other / unclassified

2 mg/kg

Oral

Subject

Mycophenolate Mofetil

Small molecule

1.5 g

Oral

Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)

Summary

Timeline

Publications

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Indications