Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

NCT00195338

Last updated date
Study Location
Pfizer Investigational Site
Luxembourg, , L-2420, Luxembourg
Contact
1-800-718-1021

FOR MORE INFORMATION

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1-800-718-1021

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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
17 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have moderate to severe active rheumatoid arthritis

- Be aged of 17 years or more

- Have inadequate response to DMards

- Give written informed consent

- Physician decides to prescribe Enbrel

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


n/a

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Official Title A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Brief Summary The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.
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 Probability Sample
Study Population Patients will be included after the physician decided to prescribe Enbrel.
Condition Rheumatoid Arthritis
Intervention Drug: etanercept
Study Groups/Cohorts 1
This is an open label, observational study.This is a post-marketing surveillance study in rheumatology practice patients in Luxemburg.Rheumatologists will be asked to document safety and adherence to therapy of Enbrel when given to adults with active rheumatoid arthritis.All patients initiated with Enbrel will be observed.
Intervention: Drug: etanercept
Publications * Not Provided

*   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: December 16, 2011)
25
Original Enrollment
 (submitted: September 13, 2005)
50
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Have moderate to severe active rheumatoid arthritis
  • Be aged of 17 years or more
  • Have inadequate response to DMards
  • Give written informed consent
  • Physician decides to prescribe Enbrel

Exclusion Criteria:

n/a

Sex/Gender
Sexes Eligible for Study:All
Ages 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Luxembourg
Removed Location Countries  
 
Administrative Information
NCT Number NCT00195338
Other Study ID Numbers 0881-101343
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Innovex, Inc
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2011