Cervarix Long-term Safety Surveillance - Full Text View

Purpose

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	Intervention
Myositis Guillain-Barre Syndrome Autoimmune Thyroiditis Multiple Sclerosis Cutaneous Lupus Lupus Erythematosus Inflammatory Arthritis Type 1 Diabetes Central Demyelination Dermatomyositis Idiopathic Thrombocytopenic Purpura Graves Disease	Biological: Cervarix Other: Data collection

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)

Resource links provided by NLM:

Genetics Home Reference related topics: Guillain-Barré syndrome idiopathic inflammatory myopathy multiple sclerosis thrombotic thrombocytopenic purpura type 1 diabetes

MedlinePlus related topics: Autoimmune Diseases Diabetes Diabetes Type 1 Guillain-Barre Syndrome Multiple Sclerosis Myositis

Drug Information available for: Human papillomavirus vaccine, L1 type 16, 18

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To assess whether the use of Cervarix® is associated with a modified risk of central demyelination. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of myositis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1515
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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

Ages Eligible for Study:	14 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498627

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01498627 History of Changes
Other Study ID Numbers:	112677
Study First Received:	December 21, 2011
Last Updated:	February 7, 2013
Health Authority:	France: Haute Autorité de Santé

Keywords provided by GlaxoSmithKline:

Cervarix
PGRx information system
Autoimmune diseases (AIDs)

Additional relevant MeSH terms:

Arthritis
Demyelinating Diseases
Dermatomyositis
Diabetes Mellitus, Type 1
Graves Disease
Guillain-Barre Syndrome
Multiple Sclerosis
Myositis
Purpura
Purpura, Thrombocytopenic
Sclerosis
Thyroiditis
Purpura, Thrombocytopenic, Idiopathic
Lupus Erythematosus, Systemic
Hashimoto Disease

Thyroiditis, Autoimmune
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Muscular Diseases
Polymyositis
Neuromuscular Diseases
Connective Tissue Diseases
Skin Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

Cervarix Long-term Safety Surveillance (PGRx)