Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00594932
• Date of registration: 04/01/2008
• Prospective Registration: No
• Primary sponsor: Oklahoma Medical Research Foundation
• Public title: Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
• Scientific title: Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
• Date of first enrolment: November 2006
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00594932
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Joan T. Merrill, M.D.
• Affiliation: Oklahoma Medical Research Foundation

• Name: Robert Clancy, PhD
• Affiliation: NYU Langone Health

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of SLE by the 1995 modification of revised ACR criteria (includes
antiphospholipid antibodies)

2. BILAG A arthritis or BILAG B arthritis with at least 6 tender and 4 swollen joints at
screening and baseline

3. Stable prednisone dose at 20 mg of less for one month at baseline.

4. If on antimalarials must be stable for at least one month at baseline

5. If on NSAIDS must be on a stable regimen for at least one month but can be prn dosing

6. Must be willing to withdraw from azathioprine or MTX at the time of screening.

7. Between ages 14 and 70

8. Women of childbearing potential must have a negative pregnancy test at screening and
at each month during the study.

9. 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.

-

Exclusion Criteria:

1. Inability to understand informed consent

2. Drug or alcohol abuse within the past six months

3. 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.

4. Unstable medical condition that, in the opinion of the investigator would
contraindicate study participation

5. 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).

6. Use of cyclosporine, leflunomide, cyclophosphamide or ay biologic agent within three
months prior to screening.

7. Participation in any clinical study of an investigational agent within three months of
screening -



Age minimum: 14 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis

Systemic Lupus Erythematosus

Intervention(s)

Drug: mycophenolate mofetil

Other: placebo

Primary Outcome(s)

Arthritis Complete Response [Time Frame: 3 months]

Secondary Outcome(s)

Major Arthritis Response [Time Frame: 3 months]

Major and Partial Clinical Response [Time Frame: 3 Months]

Secondary ID(s)

Aspreva Pharmaceuticals grant

OMRF 06-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NYU Langone Health

Results

• Results available: Yes
• Date Posted: 09/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00594932