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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00620685 |
A p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: Placebo Drug: PH-797804 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate |
Enrollment: | 27 |
Study Start Date: | February 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
Tablet, once daily for 4 weeks
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2: Experimental |
Drug: PH-797804
Tablet, 1 mg PH-797804, once daily for 4 weeks
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3: Experimental |
Drug: PH-797804
Tablet, 5 mg PH-797804, once daily for 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85013 | |
United States, Colorado | |
Pfizer Investigational Site | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33169 | |
United States, Maryland | |
Pfizer Investigational Site | |
Frederick, Maryland, United States, 21702 | |
United States, Michigan | |
Pfizer Investigational Site | |
Kalamazoo, Michigan, United States, 49007 | |
Pfizer Investigational Site | |
Bingham Farms, Michigan, United States, 48025 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Ducansville, Pennsylvania, United States, 16635 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6631005 |
Study First Received: | January 10, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00620685 |
Health Authority: | United States: Food and Drug Administration |
Arthritis, rheumatoid |
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 |