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NCT00433186 · ClinicalTrials.gov registry record · Phase 1
Mycophenolate Mofetil in Systemic Sclerosis
A Phase 1 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00433186: Completed Phase 1 study, sponsored by Boston University.
NCT00433186 is a Phase 1 study that has completed, run by Boston University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00433186, a Phase 1 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a research study of an investigational product called Mycophenolate mofetil (MMF). The study is designed to establish the safety and potential benefit of MMF. MMF has proven one of the most effective medications to date for SLE and associated nephritis. It also appears to be active in polymyositis and dermatomyositis. This medication inhibits inosine monophosphate dehydrogenase, the rate-limiting enzyme in synthesis of guanosine nucleotides. It blocks the type II isoform found in activated lymphocytes more potently than the type I isoform inhibiting both T- and B-lymphocytes. In SSc, MMF has been tried after anti-thymocyte globulin in one small open label study with efficacy with a significant improvement in skin score. We will test the safety and efficacy of MMF in SSc. All study patients will receive the study medication. The effect of the study medication will be examined in two subgroups of patients: those with early or progressive skin disease (skin substudy) and those with muscle disease (muscle substudy). The change in modified Rodnan skin score (MRSS) and creatinine phosphokinase (CK) for, respectively, the skin and muscle substudies at 6 months after treatment will be compared to baseline values.
Interventions
- DRUG Mycophenolate Mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-03 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT00433186 record still lists
NCT00433186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate Mofetil is the first listed.
NCT00433186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00433186 about?
NCT00433186 is a clinical study titled "Mycophenolate Mofetil in Systemic Sclerosis". This is a research study of an investigational product called Mycophenolate mofetil (MMF). The study is designed to establish the safety and potential benefit of MMF. MMF has proven one of the most effective medications to date for SLE and associated nephritis. It also appears to be active in polymy...
What is the current status of trial NCT00433186?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-03. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00433186?
The interventions under investigation include: Mycophenolate Mofetil (DRUG).
Who is sponsoring clinical trial NCT00433186?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00433186's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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