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Study Complete
Sponsor ID
20021629

Study of Enbrel in Rheumatoid Arthritis (RA) subjects With comorbid disorders

Sponsor ID
20021629
Clinicaltrials.gov ID
NCT00132418
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
564
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics

Timeframe: 16 weeks

Secondary Outcome Measures

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

Timeframe: 16 weeks

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Apr 2000 - Feb 2004
    Inclusion and Exclusion 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)