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Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116727
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : May 6, 2011
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:

Brief Summary:
To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: ENBREL®

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Study Type : Observational
Actual Enrollment : 5103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)
Study Start Date : October 2002
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
etanercept 50 mg/wk SC
50 mg/wk SC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA patients (by ACR criteria) starting on etanercept alone or in combination with other DMARDs

Inclusion Criteria:

  • Fulfillment of the 1987 American Rheumatism Association criteria for RA
  • Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion Criteria:

  • Currently or previously enrolled in RADIUS 1
  • Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
  • Active infections
  • Known allergy to ENBREL® or any of its components
  • Current treatment with ENBREL®
  • Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
  • Nursing or pregnant women

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 identifier (NCT number): NCT00116727

Sponsors and Collaborators
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: MD Amgen
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00116727    
Other Study ID Numbers: 20021635
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011
Keywords provided by Amgen:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors