Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Enbrel (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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; chronic pulmonary disease; pneumonia within the last year; or recurrent
bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.
Clinical Details
Official title: Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics
Secondary outcome: Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link FDA-approved Drug Labeling
Starting date: April 2000
Last updated: January 20, 2011
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