Clinical trial NCT00938015: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: postmarketing surveillance
Enbrel
psoriatic arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rheumatology centers

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.


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

Primary outcomes:
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
timeFrame: Baseline up to Year 1
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
timeFrame: Year 1 up to Year 2
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
timeFrame: Year 2 up to Year 3
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
timeFrame: Year 3 up to Year 4
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
timeFrame: Year 4 up to Year 5
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
timeFrame: Year 5 up to Year 6
Secondary outcomes:
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
timeFrame: Baseline up to Year 6
measure: Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
timeFrame: Baseline up to Month 6, 12, 18, 30, 42, 54, 66
measure: Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
timeFrame: Baseline up to Month 78
measure: Number of Joints With Active Arthritis
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
measure: Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
measure: Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
measure: Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.