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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00404157 |
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.
Condition | Intervention | Phase |
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Lupus Nephritis |
Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 140 |
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | U3388g |
Study First Received: | November 22, 2006 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00404157 |
Health Authority: | United States: Food and Drug Administration |
Lupus U2970g |
Glomerulonephritis Autoimmune Diseases Lupus Erythematosus, Systemic Urologic Diseases Rituximab |
Lupus Nephritis Nephritis Connective Tissue Diseases Kidney Diseases |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |