Cervarix Long-term Safety Surveillance (PGRx)

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.

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: Cervarix; Other: Data collection

Detailed Description

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 Type: Observational
• Enrollment (Actual): 2945

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: 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).; Other: 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.	Biological: 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).; Other: Data collection; PGRx information system

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 23, 2011

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Cervarix; Autoimmune diseases (AIDs); PGRx information system
• Other Study ID Numbers: 112677