Trial Information
Summary: Lupus
Bone & Joint Hospital Research Department, in conjunction with McBride Clinic Rheumatologists, is recruiting patients with moderate to severe systemic lupus erythematosus (SLE) for a study involving the use of an investigational medication. The purpose of the study is to assess the dose response and the dose frequency of epratuzumab (study drug) during one 12-week treatment cycle in patients with active disease.
You may be eligible for participation if you meet these criteria:
- Active moderate to severe SLE
- Age 18 years or older
- Positive ANA test result
- Lupus medication doses stable; some medications are restricted from use during the study
Patients are randomized to one 1 of 6 treatment groups, which will include study drug or placebo in addition to standard corticosteroids and any immunosuppressive medications the patient may be currently taking outside the study. Study drug or placebo drug is administered into the vein (IV infusion) weekly for the first 4 weeks after meeting qualification requirements. After this series of infusions, follow-up study visits are completed approximately every 4 weeks until Week 12, at which time the patient will have the option to continue open-label retreatment with study drug for an indefinite period of time.
Eligible patients will receive study medication and study-related treatment at no charge, as well as a stipend for visits completed.
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Contact:
Red
Bone & Joint Hospital Research Dept
1111 N. Dewey Avenue
Oklahoma City, OK 73103
Telephone: 405-552-9521
Email:
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Trial listings updated: June 1, 2008 at 6:43:00 AM