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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00619905 |
This study assessed the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: ACZ885 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months. |
Enrollment: | 53 |
Study Start Date: | December 2003 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: ACZ885 |
2: Placebo Comparator | Drug: ACZ885 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Germany | |
Novartis Investigator Site | |
Berlin, Germany | |
Novartis Investigator Site | |
Hamburg, Germany | |
Novartis Investigator Site | |
Koeln, Germany | |
Novartis Investigator Site | |
Leipzig, Germany | |
Novartis Investigator Site | |
Munich, Germany | |
Novartis Investigator Site | |
Ratingen, Germany | |
Netherlands | |
Novartis Investigator Site | |
Nijmegen, Netherlands | |
Novartis Investigator Site | |
Leiden, Netherlands | |
Switzerland | |
Novartis Investigator Site | |
Bern, Switzerland | |
Novartis Investigator Site | |
Geneva, Switzerland |
Principal Investigator: | Novartis | Novartis investigator site |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CACZ885A2101 |
Study First Received: | February 8, 2008 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00619905 |
Health Authority: | Germany: Paul-Ehrlich-Institut; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Switzerland: Swissmedic |
Rheumatoid Arthritis Anti-interleukin-1 beta ACZ885 |
Folic Acid Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases Immunoglobulins |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |