Infections, PapillomavirusPGRxNCT01498627
Cervarix Long-term Safety Surveillance
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cervarix and Data collection
- How many people
- 2,945 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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)
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix, Data collection
- Keywords
- Autoimmune diseases (AIDs), Cervarix, PGRx information system
- Medical subject headings
- Papillomavirus Infections, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervarixBiological
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).
Data collectionOther
PGRx information system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Cervarix; Other: Data collection | |
| 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. Receives: Biological: Cervarix; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
Measured: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
Measured: At Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startAug 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498627
- Sponsor's protocol ID
- 112677
- Acronym
- PGRx
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2011
- Last updated
- 6 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
- ClinicalTrials.gov ID
- NCT01498627
- Acronym / sponsor ID
- PGRx / 112677
- Conditions
- Infections, Papillomavirus
- Keywords
- Autoimmune diseases (AIDs), Cervarix, PGRx information system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,945 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Biological: Cervarix, Other: Data collectionSubjects in this group are incident cases (i.e. newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation. |
| Control Group | – | Biological: Cervarix, Other: Data collectionSubjects 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. |
Who may qualify
- Ages
- 14 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervarix3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses). | Biological | Case Group, Control Group |
| Data collectionPGRx information system | Other | Case Group, Control Group |
Primary outcome
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
Time frame: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
Time frame: At Month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination. (time frame: At Month 36). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.