Text Size

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:
NCT00116714
First received: June 30, 2005
Last updated: May 5, 2011
Last verified: May 2011
History of Changes
  Purpose

The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.


Condition Intervention
Rheumatoid Arthritis
 Drug: DMARD

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 1)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Enrollment: 4968
Study Start Date: October 2001
Study Completion Date: October 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation Drug: DMARD
All subjects were required to initiate, add or change DMARD therapy at study entry.

  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

Subjects with RA according to ACR criteria, and who are starting, adding or changing DMARD therapy, including biologics.

Criteria

Inclusion Criteria:

  • Fulfillment of the 1987 American Rheumatism Association criteria for RA
  • Currently requiring a new DMARD (change or addition)

Exclusion Criteria:

  • Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol
  • Nursing or pregnant women
  • Patients with active infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116714

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00116714     History of Changes
Other Study ID Numbers: 20021634, 016.0034
Study First Received: June 30, 2005
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
rheumatoid arthritis
RA
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 May 16, 2013