Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus, Arthritis

In brief

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.

Key facts

Study ID

NCT00594932

Run by

Oklahoma Medical Research Foundation

People needed

27

Starts

2006-11-01

Expected to finish

2009-04-01

Last updated by the study team

2020-10-09

Who can join

Age: 14 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE by the 1995 modification of revised ACR criteria (includes antiphospholipid antibodies)
• BILAG A arthritis or BILAG B arthritis with at least 6 tender and 4 swollen joints at screening and baseline
• Stable prednisone dose at 20 mg of less for one month at baseline.
• If on antimalarials must be stable for at least one month at baseline
• If on NSAIDS must be on a stable regimen for at least one month but can be prn dosing
• Must be willing to withdraw from azathioprine or MTX at the time of screening.
• Between ages 14 and 70
• Women of childbearing potential must have a negative pregnancy test at screening and at each month during the study.
• All participants (male and female) must, if fertile, agree to practice contraception during the entire course of the study. This may include barrier, oral contraceptives, depo-provera, intrauterine device and/or abstinence.

You may not qualify if…

• Inability to understand informed consent
• Drug or alcohol abuse within the past six months
• In the opinion of the investigator, it is not likely the patient can comply with the protocol for any reason, or participation in the protocol is not in the patient's best interest.
• Unstable medical condition that, in the opinion of the investigator would contraindicate study participation
• History of malignancy (except for basal cell carcinoma at any time and/or cervical cancer or squamous cell cancer at least five years previous to screening).
• Use of cyclosporine, leflunomide, cyclophosphamide or ay biologic agent within three months prior to screening.
• Participation in any clinical study of an investigational agent within three months of screening -

Where it is running

• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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