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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00293826 |
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: AMG 108 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis. |
Enrollment: | 813 |
Study Start Date: | March 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
196 subjects
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Drug: AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
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3: Experimental
196 subjects
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Drug: AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
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2: Experimental
196 subjects
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Drug: AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
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4: Placebo Comparator
196 subjects
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Drug: Placebo
Placebo via SC (subcutaneous) injection every 4 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050168 |
Study First Received: | February 17, 2006 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00293826 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ACR criteria methotrexate DMARDs patient reported outcomes joint assessment |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |