The objective of this study was to evaluate the safety of 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 andat least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection)	Drug: Enbrel	Phase IV

Further Study Details: 

Primary Outcomes: Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics.
Secondary Outcomes: Inceftions associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events.
Expected Total Enrollment:  1000

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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
• Recurrent bronchitis
• Sinusitis or urinary tract infection)
• Able to self-inject study drug

Exclusion Criteria:

• Previous use of anti-TNFmonocloncal antibody
• Receipt of anti-CD4 or diphtheria interlukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count
• Receipt of intra-articular corticosteroids during 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, MI within 12 months of screening, angina pectoris, uncontrolled hypertension, cancer, HIV positive)

Study ID Numbers:  20021629
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00132418
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23