Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy
May 5, 2011 updated by: Amgen
Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
4968
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation
|
All subjects were required to initiate, add or change DMARD therapy at study entry.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
June 30, 2005
First Posted (Estimate)
July 1, 2005
Study Record Updates
Last Update Posted (Estimate)
May 6, 2011
Last Update Submitted That Met QC Criteria
May 5, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20021634
- 016.0034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.