We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00116727
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : May 6, 2011
Sponsor:
Collaborators:
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Amgen

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®

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
Primary Completion Date : June 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Drug
etanercept 50 mg/wk SC
Drug: ENBREL®
50 mg/wk SC




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00116727


Sponsors and Collaborators
Amgen
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00116727     History of Changes
Other Study ID Numbers: 20021635
016.0035
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011

Keywords provided by Amgen:
Rheumatoid Arthritis
DMARD

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents