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Completed

NCT Number: NCT00938015

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

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.

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

This is a non-interventional study

Primary outcomes

  1. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1

    Time frame: 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.

  2. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2

    Time frame: 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.

  3. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3

    Time frame: 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.

  4. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4

    Time frame: 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.

  5. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5

    Time frame: 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.

  6. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants With at Least 1 Adverse Event (AE) Per Year

    Time frame: Baseline 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.

  2. Incidence of Adverse Events and Serious Adverse Events Per Participant-Year

    Time frame: Baseline up to Month 6, 12, 18, 30, 42, 54, 66

    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.

  3. Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment

    Time frame: Baseline up to Month 78

  4. Number of Joints With Active Arthritis

    Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

    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.

  5. Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation

    Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

    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.

  6. Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation

    Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

    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.

  7. Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)

    Time frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: PROVE

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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