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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00446784 |
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate
Condition | Intervention | Phase |
---|---|---|
Arthritis, Rheumatoid |
Drug: CE-224,535 Drug: Methotrexate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Pfizer Investigational Site | |
Ocala, Florida, United States, 34471 | |
Pfizer Investigational Site | |
Ocala, Florida, United States, 34474 | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33169 | |
United States, Michigan | |
Pfizer Investigational Site | |
Kalamazoo, Michigan, United States, 49007 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Ducansville, Pennsylvania, United States, 16635 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A6341006 |
Study First Received: | March 9, 2007 |
Last Updated: | October 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00446784 |
Health Authority: | United States: Food and Drug Administration |
Folic Acid Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
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 |