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An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)

28. maj 2014 opdateret af: Pfizer

An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study

With the new reimbursement criteria, we want:

To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.

To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

100 patients will be followed for at least 1 year

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

140

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
        • Herestraat 49

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

All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion. It is requested to include patients in a consecutive manner as much as possible.

Beskrivelse

Inclusion Criteria:

  • Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
  • Patients ≥18 year
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

N/A

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
Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria
Andet: Enbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Weeks of Etanercept Treatment
Tidsramme: Baseline up to end of study (90 weeks)
Average duration of time in weeks for treatment with etanercept was reported.
Baseline up to end of study (90 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Weeks of Off-Treatment
Tidsramme: Baseline up to end of study (90 weeks)
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
Baseline up to end of study (90 weeks)
Psoriasis Area and Severity Index (PASI) Score
Tidsramme: Start and end of cycle 1, 2, 3
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Start and end of cycle 1, 2, 3
Percentage of Body Surface Area (BSA) Affected by Psoriasis
Tidsramme: Start and end of cycle 1, 2, 3
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
Start and end of cycle 1, 2, 3
Number of Participants With Reasons for Treatmant Discontinuation
Tidsramme: Baseline up to end of study (90 weeks)
Number of participants who discontinued etanercept before completing the study was reported.
Baseline up to end of study (90 weeks)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Received Continuous Treatment
Tidsramme: Baseline up to end of study (90 weeks)
Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
Baseline up to end of study (90 weeks)
Number of Participants Who Received Intermittent Treatment
Tidsramme: Baseline up to end of study (90 weeks)
Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
Baseline up to end of study (90 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

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.

Hjælpsomme links

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. september 2011

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

30. september 2011

Først indsendt, der opfyldte QC-kriterier

15. marts 2012

Først opslået (Skøn)

19. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1801314
  • BEFLEX

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 .

Kliniske forsøg med Plaque Psoriasis patienter

Kliniske forsøg med Enbrel treatment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner