- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00938015
Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis (PROVE)
27. marts 2013 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
303
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Leuven, Belgien, 3000
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
rheumatology centers
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
Tidsramme: 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
Tidsramme: Year 1 up to Year 2
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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 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
Tidsramme: 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
Tidsramme: Year 3 up to Year 4
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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 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline up to Month 78
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Baseline up to Month 78
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Number of Joints With Active Arthritis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2004
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
10. juli 2009
Først indsendt, der opfyldte QC-kriterier
10. juli 2009
Først opslået (Skøn)
13. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. marts 2013
Sidst verificeret
1. marts 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0881A-101698
- B1801107
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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NovartisAfsluttetArthritis, Juvenil ReumatoidItalien
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Centocor, Inc.Afsluttet
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GeneScience Pharmaceuticals Co., Ltd.Ikke rekrutterer endnuAktiv systemisk juvenil idiopatisk arthritisKina
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Institut National de la Santé Et de la Recherche...AfsluttetSystemisk opstået juvenil idiopatisk arthritisFrankrig