Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Enbrel

• Registration Number: NCT00132418
• Lead Sponsor: Amgen

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; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Enbrel	Enbrel	Enbrel

Primary Outcome Measures

Name	Time	Method
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics	16 weeks

Secondary Outcome Measures

Name	Time	Method
Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events	16 weeks