PGRx: Cervarix Long-term Safety Surveillance

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01498627
• Collaborator: (none)
• Enrollment: 2,945
• Duration (Months): 76

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infections, Papillomavirus	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 Design

• Study Type: Observational
• Actual Enrollment: 2945 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. To assess whether the use of Cervarix® is associated with a modified risk of central demyelination. [At Month 36]

2. To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes. [At Month 36]

3. To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus. [At Month 36]

4. To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis. [At Month 36]

5. To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura. [At Month 36]

6. To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus. [At Month 36]

7. To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus. [At Month 36]

8. To assess whether the use of Cervarix® is associated with a modified risk of myositis. [At Month 36]

9. To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis. [At Month 36]

10. To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome. [At Month 36]

11. To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis [At Month 36]

12. To assess whether the use of Cervarix® is associated with a modified risk of Graves disease. [At Month 36]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01498627
• Other Study ID Numbers: 112677
• First Posted: Dec 23, 2011
• Last Update Posted: Apr 6, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by GlaxoSmithKline: Autoimmune diseases (AIDs); Cervarix; PGRx information system

Study Results

No Results Posted as of Apr 6, 2015