|
|
|
|
|
|
Sponsors and Collaborators: |
Amgen Immunex Corporation |
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00132418 |
The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: Enbrel Drug: Placebo |
Phase IV |
MedlinePlus related topics: | Rheumatoid Arthritis |
Drug Information available for: | Etanercept |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | Double-Blind, Randomized, Placebo-Controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders |
Enrollment: | 564 |
Study Start Date: | April 2000 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo: Placebo Comparator
placebo
|
Drug: Placebo
Placebo
|
Enbrel: Experimental
Enbrel
|
Drug: Enbrel
Enbrel
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Active RA - Documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - Able to self-inject study drug Exclusion Criteria: - Previous use of anti-tumor necrosis factor (TNF) monoclonal antibody - Receipt of anti-CD4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count - Receipt of intra-articular corticosteroids within 2 weeks before screening - Receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - Significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction [MI] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or HIV positive)
AmgenTrials clinical trials website 
  |
Clinical Study Results website - Results posting for study 20021629 
  |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20021629 |
First Received: | August 19, 2005 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00132418 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|