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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 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.

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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.

Interventions

  • OTHER placebo
  • DRUG mycophenolate mofetil

Study Locations (1)

Oklahoma

  • Oklahoma Medical Research Foundation - Oklahoma City

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2006-11
Est. Completion 2009-04
Phase Phase 1

What the Registry Record Tells You About NCT00594932

The ClinicalTrials.gov registry entry for NCT00594932 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower). The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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