Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis (PROVE)
27 marzo 2013 aggiornato da: Pfizer
A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
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.
Panoramica dello studio
Tipo di studio
Osservativo
Iscrizione (Effettivo)
303
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Leuven, Belgio, 3000
- Pfizer Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
rheumatology centers
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
PsA Patients (New)
New patients
|
This is a non-interventional study
|
|
PsA Patients
CU patients
|
This is a non-interventional study
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
Lasso di tempo: 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
|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
Lasso di tempo: 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
|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
Lasso di tempo: 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
|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
Lasso di tempo: 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
|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
Lasso di tempo: 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
|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
Lasso di tempo: 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.
|
Baseline up to Year 6
|
|
Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
Lasso di tempo: 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.
|
Baseline up to Month 6, 12, 18, 30, 42, 54, 66
|
|
Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
Lasso di tempo: Baseline up to Month 78
|
Baseline up to Month 78
|
|
|
Number of Joints With Active Arthritis
Lasso di tempo: 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.
|
Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
|
|
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
Lasso di tempo: 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.
|
Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
|
|
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
Lasso di tempo: 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.
|
Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
|
|
Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
Lasso di tempo: 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.
|
Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2004
Completamento primario (Effettivo)
1 aprile 2012
Completamento dello studio (Effettivo)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
10 luglio 2009
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2009
Primo Inserito (Stima)
13 luglio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 maggio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 marzo 2013
Ultimo verificato
1 marzo 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0881A-101698
- B1801107
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .