Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborators:
New York University School of Medicine NYU Langone Health