ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders

This study has been completed.

Sponsors and Collaborators: Amgen
Immunex Corporation
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00132418
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Enbrel
Drug: Placebo
Phase IV

MedlinePlus related topics:   Rheumatoid Arthritis   

Drug Information available for:   Etanercept   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:   Double-Blind, Randomized, Placebo-Controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment:   564
Study Start Date:   April 2000
Study Completion Date:   February 2004
Primary Completion Date:   February 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo: Placebo Comparator
placebo
Drug: Placebo
Placebo
Enbrel: Experimental
Enbrel
Drug: Enbrel
Enbrel

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132418

Sponsors and Collaborators
Amgen
Immunex Corporation

Investigators
Study Director:     MD     Amgen    
  More Information


AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
 
Clinical Study Results website - Results posting for study 20021629  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   Amgen Inc. ( Global Development Leader )
Study ID Numbers:   20021629
First Received:   August 19, 2005
Last Updated:   February 20, 2008
ClinicalTrials.gov Identifier:   NCT00132418
Health Authority:   United States: Food and Drug Administration

Keywords provided by Amgen:
RA  
rheumatoid arthritis  
rheumatoid arthritis and at least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection)  

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Lung Diseases
Arthritis
Connective Tissue Diseases
Diabetes Mellitus
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2008




Links to all studies - primarily for crawlers