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Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

Last updated on November 21, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Luxembourg, , L-2420 Luxembourg
Contact
1-800-718-1021
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.
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- 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
NCT00195338
Pfizer
Completed
Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

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Descriptive Information
Brief TitleStudy Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Official TitleA Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients will be included after the physician decided to prescribe Enbrel.
ConditionRheumatoid Arthritis
InterventionDrug: etanercept
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: December 16, 2011)
25
Original Enrollment
 (submitted: September 13, 2005)
50
Actual Study Completion DateDecember 2010
Actual Primary Completion DateDecember 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
Ages17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesLuxembourg
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195338
Other Study ID Numbers0881-101343
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsInnovex, Inc
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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