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

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ClinicalTrials.gov Identifier: NCT00132418
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : January 21, 2011
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Enbrel Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders
Study Start Date : April 2000
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
Placebo
Experimental: Enbrel
Enbrel
Drug: Enbrel
Enbrel



Primary Outcome Measures :
  1. Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132418


Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00132418     History of Changes
Other Study ID Numbers: 20021629
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors