Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

This study has been completed.
Sponsor:
Collaborators:
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00116727
First received: June 30, 2005
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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 Intervention
Rheumatoid Arthritis
Drug: ENBREL®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)

Resource links provided by NLM:


Further study details as provided by Amgen:

Enrollment: 5103
Study Start Date: October 2002
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug
etanercept 50 mg/wk SC
Drug: ENBREL®
50 mg/wk SC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00116727

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00116727     History of Changes
Other Study ID Numbers: 20021635, 016.0035
Study First Received: June 30, 2005
Last Updated: May 5, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014