Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
NCT00938015
ABOUT THIS STUDY
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- 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
NA
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Descriptive Information | ||||
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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 |
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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 | 303 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria: NA | |||
Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | March 2013 |