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Cervarix Long-term Safety Surveillance

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections, Papillomavirus

Intervention: Cervarix (Biological); Data collection (Other)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.

To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.

To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.

To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.

To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.

To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.

To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.

To assess whether the use of Cervarix® is associated with a modified risk of myositis.

To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.

To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.

To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis

To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.

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

Minimum age: 14 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 2008
Last updated: April 2, 2015

Page last updated: August 20, 2015

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