Rheumatoid Arthritis DMARD Intervention and UtilizationStudy
Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)
2 other identifiers
observational
5,103
0 countries
N/A
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2002
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 6, 2011
May 1, 2011
5.7 years
June 30, 2005
May 5, 2011
Conditions
Keywords
Study Arms (1)
Drug
etanercept 50 mg/wk SC
Interventions
Eligibility Criteria
RA patients (by ACR criteria) starting on etanercept alone or in combination with other DMARDs
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Immunex Corporationcollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Related Publications (1)
Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.
PMID: 20952478DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
October 1, 2002
Primary Completion
June 1, 2008
Study Completion
October 1, 2008
Last Updated
May 6, 2011
Record last verified: 2011-05