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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 Comparator: Placebo
placebo
Drug: Placebo
Placebo
Experimental: Enbrel
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00132418     History of Changes
Other Study ID Numbers: 20021629
Study First Received: August 19, 2005
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

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
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014