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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00038298 |
This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks.
They visit the study facility at least 11 times while participating in the study.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Placebo Drug: AMG 719 Drug: AGM 719 Drug: placebo to AMG 719 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate |
Enrollment: | 53 |
Study Start Date: | April 2002 |
Study Completion Date: | May 2004 |
Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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50 mg: Experimental
50 mg 3 times weekly
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Drug: AMG 719
50 mg 3 times weekly
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400 mg: Experimental
400 mg 3 times weekly
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Drug: AMG 719
400 mg 3 times weekly
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200 mg: Experimental
200 mg 3 times weekly
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Drug: AGM 719
200 mg 3 times weekly
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Placebo: Placebo Comparator
Placebo comparator associated with each active arm. (3:1 active vs placebo)
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Drug: Placebo
Placebo given 3 times weekly
Drug: placebo to AMG 719
Placebo dose given 3 times weekly
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Arizona | |
Research Site | |
Phoenix, Arizona, United States | |
Research Site | |
Paradise Valley, Arizona, United States | |
United States, California | |
Research Site | |
Santa Maria, California, United States | |
Research Site | |
San Diego, California, United States | |
United States, Indiana | |
Research Site | |
Evansville, Indiana, United States | |
Research Site | |
Indianapolis, Indiana, United States | |
United States, Maine | |
Research Site | |
Bangor, Maine, United States | |
United States, Maryland | |
Research Site | |
Frederick, Maryland, United States | |
Research Site | |
Hagerstown, Maryland, United States | |
United States, New Jersey | |
Research Site | |
Voorhees, New Jersey, United States | |
United States, Ohio | |
Research Site | |
Chardon, Ohio, United States | |
United States, Pennsylvania | |
Research Site | |
Duncansville, Pennsylvania, United States | |
Research Site | |
Wyomissing, Pennsylvania, United States | |
United States, Texas | |
Research Site | |
Dallas, Texas, United States | |
United States, Wisconsin | |
Research Site | |
Brookfield, Wisconsin, United States |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010238 |
Study First Received: | May 29, 2002 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00038298 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms 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 |