Study identification

PURI

https://redirect.ema.europa.eu/resource/31680

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

Contact details

Lamiae Grimaldi

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline
Study protocol
Initial protocol

gsk-112677-protocol-part2-redact

English (1.55 MB - PDF)View document
Updated protocol

gsk-112677-protocol-part1-redact

English (1.77 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable