Cervarix Long-term Safety Surveillance (PGRx)
2 april 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Observationell
Inskrivning (Faktisk)
2945
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
14 år till 79 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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.
|
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).
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.
|
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).
PGRx information system
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
Tidsram: At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
Tidsram: At Month 36
|
At Month 36
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2008
Primärt slutförande (Faktisk)
1 december 2014
Avslutad studie (Faktisk)
1 december 2014
Studieregistreringsdatum
Först inskickad
21 december 2011
Först inskickad som uppfyllde QC-kriterierna
21 december 2011
Första postat (Uppskatta)
23 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 112677
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .