Clinical trial NCT01498627: Cervarix Long-term Safety Surveillance
Official title: Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Keywords: Autoimmune diseases (AIDs)
Cervarix
PGRx information system
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 2945
Sex: ALL
Minimum age (years): 14
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of myositis.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
timeFrame: At Month 36
measure: To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
timeFrame: At Month 36
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: