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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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