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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 is a Phase 1 study that has completed, run by Boston University. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00433186
The ClinicalTrials.gov registry entry for NCT00433186 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate Mofetil is the first listed.
NCT00433186 reports 0 study locations.
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.
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