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

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00132418
First received: August 19, 2005
Last updated: January 20, 2011
Last verified: January 2011

August 19, 2005
January 20, 2011
April 2000
February 2004   (final data collection date for primary outcome measure)
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics.
Complete list of historical versions of study NCT00132418 on ClinicalTrials.gov Archive Site
Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Inceftions associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events.
Not Provided
Not Provided
 
Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Enbrel
    Enbrel
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
  • Experimental: Enbrel
    Enbrel
    Intervention: Drug: Enbrel
Weisman MH, Paulus HE, Burch FX, Kivitz AJ, Fierer J, Dunn M, Kerr DR, Tsuji W, Baumgartner SW. A placebo-controlled, randomized, double-blinded study evaluating the safety of etanercept in patients with rheumatoid arthritis and concomitant comorbid diseases. Rheumatology (Oxford). 2007 Jul;46(7):1122-5. Epub 2007 Apr 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
564
February 2004
February 2004   (final data collection date for primary outcome measure)

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00132418
20021629
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Immunex Corporation
Study Director: MD Amgen
Amgen
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP