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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Leuven, , 3000 Belgium
Contact
1-800-718-1021
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

NCT00938015
Pfizer
Completed
Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

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Descriptive Information
Brief TitleStudy Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
Official TitleA Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationrheumatology centers
ConditionArthritis, Psoriatic
InterventionOther: 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 StatusCompleted
Actual Enrollment
 (submitted: March 27, 2013)
303
Original Estimated Enrollment
 (submitted: July 10, 2009)
200
Actual Study Completion DateApril 2012
Actual Primary Completion DateApril 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBelgium
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00938015
Other Study ID Numbers0881A-101698
B1801107
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2013

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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