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NCT00594932 · ClinicalTrials.gov registry record · Phase 1
Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
A Phase 1 study of Systemic Lupus Erythematosus and Arthritis, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00594932: Completed Phase 1 study of Systemic Lupus Erythematosus and Arthritis, sponsored by Oklahoma Medical Research Foundation.
NCT00594932 is a Phase 1 study of Systemic Lupus Erythematosus and Arthritis that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 27 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00594932, a Phase 1 study of Systemic Lupus Erythematosus and Arthritis, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis. In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil or placebo (inert pills) for three months. At the end of three months all patients will receive mycophenolate mofetil for three additional months. The effectiveness on arthritis and other symptoms of lupus will be measured by joint counts and by the BILAG instrument (a measure of overall lupus disease activity. Additionally special blood tests aimed at understanding the biologic effects of mycophenolate mofetil will also be performed at some visits. The primary outcome measurement will be the safety and effectiveness of this treatment (as compared to placebo) at the three month point. The trial will continue in a blinded fashion (neither the investigator or the participants know who is getting mycophenolate and who is getting placebo) until 24 patients have completed the first three months of the protocol.
Primary Outcome
Complete response at three months (This is defined as \</= 0.25 of the total tender plus swollen joints observed at baseline and British Isles Lupus Assessment Group (BILAG) index C (mild) or D (no longer present) score in the Musculoskeletal system), comparing treatment to placebo group as complete responder or not complete responder. This was an intent to treat analysis so dropouts were counted as non-responders.
Conditions Studied
Interventions
- OTHER placebo
- DRUG mycophenolate mofetil
Study Locations (1)
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00594932 record still lists
NCT00594932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00594932 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT00594932 about?
NCT00594932 is a clinical study titled "Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis". We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis. In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil or placebo (inert pills) for three months. At the end of three months all patients will receive mycophenolate mo...
What is the current status of trial NCT00594932?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-11. Estimated completion is 2009-04.
What conditions does trial NCT00594932 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Arthritis.
What interventions are being tested in trial NCT00594932?
The interventions under investigation include: placebo (OTHER), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00594932?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00594932 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00594932's enrollment target sits among peer trials
27 86th of 99 higher than 14 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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.
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