CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
Mycophenolate mofetil +2 moredrug
Likely dose
Cyclophosphamide 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00883129
NCT00883129Phase 2Completed

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)

Michael Roth·interventional·Posted Apr 17, 2009·Updated Feb 10, 2017

In Brief

A Phase 2 clinical trial evaluating Mycophenolate mofetil, Cyclophosphamide, and 1 other intervention for Scleroderma and Interstitial Lung Disease. Completed, enrolled 142 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.2 years ago

Interventions

Mycophenolate mofetildrug

24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated

Cyclophosphamidedrug

12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated

Placebodrug

12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years.