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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00282347 |
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 |
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
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Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Jay Garg, M.D | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | U2970g |
Study First Received: | January 24, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00282347 |
Health Authority: | United States: Food and Drug Administration |
Class IV LN Lupus LUNAR LN |
Glomerulonephritis Autoimmune Diseases Lupus Nephritis Rituximab Methylprednisolone Methylprednisolone acetate Prednisolone acetate Urologic Diseases |
Lupus Erythematosus, Systemic Nephritis Prednisolone Connective Tissue Diseases Mycophenolate mofetil Kidney Diseases Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Immunologic Factors Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Immunosuppressive Agents |
Hormones Neuroprotective Agents Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |