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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00808210 |
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: infliximab Drug: methotrexate Drug: methylprednisolone Drug: ocrelizumab Drug: sham |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
Official Title: | A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab |
Estimated Enrollment: | 1 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenouse repeating dose
Drug: ocrelizumab
Intravenous repeating dose
Drug: sham
Intravenouse repeating dose
|
B: Active Comparator |
Drug: infliximab
Intravenouse repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenouse repeating dose
Drug: sham
Intravenouse repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Genentech Trial Information Support Line | 888-662-6728 |
Study Director: | William Reiss, Pharm.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | ACT4562g |
Study First Received: | December 11, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00808210 |
Health Authority: | United States: Food and Drug Administration |
RA Arthritis |
Autoimmune Diseases Infliximab Methylprednisolone Joint Diseases Arthritis, Rheumatoid Methylprednisolone acetate Prednisolone acetate Rheumatic Diseases |
Adalimumab Folic Acid Musculoskeletal Diseases Arthritis Prednisolone Connective Tissue Diseases Methotrexate Methylprednisolone Hemisuccinate |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Neuroprotective Agents Therapeutic Uses Abortifacient Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Glucocorticoids Protective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |