Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

NCT00116727

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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:MDAmgen
PRS Account Amgen
Verification Date May 2011