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Cervarix Long-term Safety Surveillance (PGRx)

2. april 2015 opdateret af: GlaxoSmithKline

Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)

This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx.

system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2945

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

14 år til 79 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects reporting an Autoimmune diseases (AID) in the previous 12 months before recruitment consultation and those whose AID is reported by physicians in general practice

Beskrivelse

Inclusion Criteria:

  • Male and female
  • Age 14 to 79 years-old (included)
  • Patient residing in France
  • Patient accepting to participate in the study
  • Patient can read and respond to a telephone interview

Exclusion Criteria:

  • Prior reported history of the disease
  • Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
  • Refusal to participate

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Case Group
Subjects in this group are incident cases (i.e. newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation.
Biologisk: Cervarix
3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
Andet: Data collection
PGRx information system
Control Group
Subjects selected from the pool of potential referents reported by physicians in general practice, who meet the same general inclusion and exclusion criteria as the cases.
Biologisk: Cervarix
3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
Andet: Data collection
PGRx information system

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
Tidsramme: At Month 36
At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
Tidsramme: At Month 36
At Month 36

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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. august 2008

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

21. december 2011

Først indsendt, der opfyldte QC-kriterier

21. december 2011

Først opslået (Skøn)

23. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 112677

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 Infektioner, papillomavirus

Kliniske forsøg med Cervarix

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner