Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis (PROVE)
27. března 2013 aktualizováno: 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.
Přehled studie
Typ studie
Pozorovací
Zápis (Aktuální)
303
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Leuven, Belgie, 3000
- Pfizer Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
rheumatology centers
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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PsA Patients (New)
New patients
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This is a non-interventional study
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PsA Patients
CU patients
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This is a non-interventional study
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
Časové okno: Baseline up to Year 1
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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.
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Baseline up to Year 1
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
Časové okno: 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.
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Year 1 up to Year 2
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
Časové okno: Year 2 up to Year 3
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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.
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Year 2 up to Year 3
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
Časové okno: 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.
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Year 3 up to Year 4
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
Časové okno: Year 4 up to Year 5
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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.
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Year 4 up to Year 5
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
Časové okno: Year 5 up to Year 6
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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.
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Year 5 up to Year 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
Časové okno: Baseline up to Year 6
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Baseline up to Year 6
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Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
Časové okno: Baseline up to Month 6, 12, 18, 30, 42, 54, 66
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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.
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Baseline up to Month 6, 12, 18, 30, 42, 54, 66
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Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
Časové okno: Baseline up to Month 78
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Baseline up to Month 78
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Number of Joints With Active Arthritis
Časové okno: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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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.
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Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
Časové okno: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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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.
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Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
Časové okno: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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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.
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Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
Časové okno: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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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.
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Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2004
Primární dokončení (Aktuální)
1. dubna 2012
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
10. července 2009
První předloženo, které splnilo kritéria kontroly kvality
10. července 2009
První zveřejněno (Odhad)
13. července 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
27. května 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. března 2013
Naposledy ověřeno
1. března 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0881A-101698
- B1801107
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .