Study of Cervarix & Idiopathic Thrombocytopenic Purpura using the PGRx information system

Study identification

• EU PAS number:
  EUPAS8093
• Study ID:
  31680
• Official title and acronym:
  Study of Cervarix & Idiopathic Thrombocytopenic Purpura using the PGRx information system
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  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.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)
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Studies, LA-SER Research

France

United Kingdom

Study timelines

Date when funding contract was signed

Actual:01/08/2008

Study start date

Actual:01/08/2008

Date of final study report

Actual:21/01/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable