Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

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NCT00938015

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Study Location
Pfizer Investigational Site
Leuven, , 3000, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic 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

- Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type

- At least 18 years old

- Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type

- Physician decides to prescribe Enbrel or patient is already on Enbrel

- Give written informed consent at time of inclusion to study

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


NA

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
Official Title A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
Brief Summary The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population rheumatology centers
Condition Arthritis, Psoriatic
Intervention Other: Questionnaire
This is a non-interventional study
Study Groups/Cohorts
  • PsA Patients (New)
    New patients
    Intervention: Other: Questionnaire
  • PsA Patients
    CU patients
    Intervention: Other: Questionnaire
Publications * de Vlam K, Boone C, The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23.

*   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: March 27, 2013)		303
Original Estimated Enrollment
 (submitted: July 10, 2009)		200
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
  • At least 18 years old
  • Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
  • Physician decides to prescribe Enbrel or patient is already on Enbrel
  • Give written informed consent at time of inclusion to study

Exclusion Criteria:

NA

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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00938015
Other Study ID Numbers 0881A-101698
B1801107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2013