Status:
COMPLETED
Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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; chro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00132418
Start Date
April 1 2000
End Date
February 1 2004
Last Update
January 21 2011
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