A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g|
- Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.
- Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
- Serum rituximab levels
- Circulating B-cell counts.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404157
|Study Director:||Jay Garg, M.D.||Genentech|