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

Arthritis, Psoriatic Clinical Trial

— PROVE  

Official title:

A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938015
• Other study ID #: 0881A-101698
• Secondary ID: B1801107
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: March 27, 2013
• Start date: October 2004
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Other:
• Questionnaire
This is a non-interventional study
• Questionnaire
This is a non-interventional study

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline up to Year 1	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Year 1 up to Year 2	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Year 2 up to Year 3	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Year 3 up to Year 4	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Year 4 up to Year 5	Yes
Primary	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Year 5 up to Year 6	Yes
Secondary	Percentage of Participants With at Least 1 Adverse Event (AE) Per Year	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to Year 6	Yes
Secondary	Incidence of Adverse Events and Serious Adverse Events Per Participant-Year	Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.	Baseline up to Month 6, 12, 18, 30, 42, 54, 66	Yes
Secondary	Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment		Baseline up to Month 78	No
Secondary	Number of Joints With Active Arthritis	Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	No
Secondary	Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation	Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	No
Secondary	Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation	Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	No
Secondary	Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)	HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78	No

External Links

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