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Trial record 1 of 1 for:    NCT00116727
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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

Tracking Information
First Submitted Date June 30, 2005
First Posted Date July 1, 2005
Last Update Posted Date May 6, 2011
Study Start Date October 2002
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rheumatoid Arthritis DMARD Intervention and UtilizationStudy
Official Title Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)
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®.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population RA patients (by ACR criteria) starting on etanercept alone or in combination with other DMARDs
Condition Rheumatoid Arthritis
Intervention Drug: ENBREL®
50 mg/wk SC
Study Groups/Cohorts Drug
etanercept 50 mg/wk SC
Intervention: Drug: ENBREL®
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February¬†11,¬†2008)
5103
Original Enrollment Not Provided
Actual Study Completion Date October 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00116727
Other Study ID Numbers 20021635
016.0035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor Amgen
Collaborators
  • Immunex Corporation
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date May 2011