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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: Completed Phase 2 study, sponsored by Michael Roth.
NCT00883129 is a Phase 2 study that has completed, run by Michael Roth. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.
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 |
What the finished NCT00883129 record still lists
NCT00883129 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00883129 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00883129's enrollment target sits among peer trials
142 507th of 2000 higher than 1,491 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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