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| Sponsored by: |
Genentech |
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00282347 |
Purpose
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with MMF compared with placebo in combination with mycophenolate mofetil (MMF) in subjects diagnosed with ISN/RPS 2003 Class III or IV Lupus Nephritis.
| Condition | Intervention | Phase |
|
Lupus Nephritis |
Drug: corticosteroids Drug: methylprednisolone Drug: mycophenolate mofetil Drug: placebo Drug: rituximab |
Phase III |
| Drug Information available for: | Methylprednisolone Rituximab Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis |
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
|
| 2: Placebo Comparator |
Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose
|
Eligibility
| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 61 Study Locations |
| Genentech |
| Study Director: | Jay Garg, M.D | Genentech |
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | U2970g |
| First Received: | January 24, 2006 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00282347 |
| Health Authority: | United States: Food and Drug Administration |
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