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Sponsors and Collaborators: |
Genentech Hoffmann-La Roche |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00539838 |
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: ocrelizumab Drug: placebo Drug: methylprednisolone Drug: corticosteroids Drug: immunosuppressive regime |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus |
Estimated Enrollment: | 423 |
Study Start Date: | December 2007 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ocrelizumab
Intravenous repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: corticosteroids
Oral repeating dose
Drug: immunosuppressive regime
Oral repeating dose
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2: Placebo Comparator |
Drug: placebo
Intravenous repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: corticosteroids
Oral repeating dose
Drug: immunosuppressive regime
Oral repeating dose
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Jorn Drappa, M.D., Ph.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | ACT4071g, WA20499 |
Study First Received: | October 3, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00539838 |
Health Authority: | United States: Food and Drug Administration |
SLE |
Autoimmune Diseases Lupus Erythematosus, Systemic Methylprednisolone Prednisolone |
Connective Tissue Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones |
Neuroprotective Agents Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |