Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00883129 · ClinicalTrials.gov registry record · Phase 2
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
A Phase 2 study, sponsored by Michael Roth.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT00883129 is a Phase 2 study that has completed, run by Michael Roth. The registered enrollment target is 142 participants.
The verdict
NCT00883129, a Phase 2 study, has completed, sponsored by Michael Roth.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG Placebo
- DRUG Mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00883129
The ClinicalTrials.gov registry entry for NCT00883129 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Roth, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00883129 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00883129 about?
NCT00883129 is a clinical study titled "Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)". 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...
What is the current status of trial NCT00883129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2009-09. Estimated completion is 2015-11.
What interventions are being tested in trial NCT00883129?
The interventions under investigation include: Cyclophosphamide (DRUG), Placebo (DRUG), Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00883129?
This trial is sponsored by Michael Roth, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.