Phase 2
N=27
Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Systemic Lupus Erythematosus · Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00594932 ↗Enrolled (actual)
27
Serious AEs
10.5%
Results posted
Oct 2020
Primary outcome: Primary: Arthritis Complete Response — 4; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mycophenolate mofetil (Drug); placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Oklahoma Medical Research Foundation
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arthritis Complete Response |
4; 0 | — |
| SECONDARY Major Arthritis Response |
5; 0 | =0.041 sig |
| SECONDARY Major and Partial Clinical Response |
9; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT00594932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.