SpondyloarthritisPAPLORNCT03713736
Papillomavirus Load in Rheumatic Inflammatory Diseases
A study testing Cervical smear, Pregnancy test and Sexual activity questionnary in people with Spondyloarthritis and Rhumatoid Arthisis, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Spondyloarthritis, Rhumatoid Arthisis
- What is being tested?
- Cervical smear, Pregnancy test and Sexual activity questionnary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Jan 2020to 9 Jan 2024
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman between 18 and 65 years old
- Patient with rheumatoid arthritis as defined in 2010 ACR/EULAR criteria or with spondyloarthritis as defined in 2009 ASAS criteria
- Patient able to understand the objectives of the study and give documented informed consent
- Patient affiliated to a social security scheme
Who cannot join
- Pregnant or breastfeeding patient
- Patient with a history of cervical cancer
- Patient under juridical protection
- Patient unable to provide informed consent due to linguistic or psychic impairment
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Bron, 69677
Gery Lamblin, MD, 04.27.85.53.53 ext. +33, gery.lamblin@chu-lyon.fr
Gery Lamblin
- Not yet recruiting
Hopital Edouard Herriot - service de rhumatologie
Lyon, 69003
Emmanuelle VIGNOT, MD, 04.72.11.74.79 ext. +33, emmanuelle.vignot@chu-lyon.fr
Emmanuelle Vignot, MD
- Recruiting
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69 495
Fabienne Coury-lucas, MD, 478861231 ext. +33, fabienne.coury-lucas@chu-lyon.fr
Muriel PIPERNO, MD
About this study
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.
Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.
Read more
In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.
Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.
- Conditions
- Spondyloarthritis, Rhumatoid Arthisis
- Being tested
- Cervical smear, Pregnancy test, Sexual activity questionnary
- Keywords
- HPV infection, Spondyloarthritis, Rhumatoid Arthritis, Cervical smear, cervical cancer screening
- Medical subject headings
- Spondylarthritis, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical smearDiagnostic test
Also called HPV test
Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.
Pregnancy testDiagnostic test
Urinary pregnancy test
Sexual activity questionnaryBehavioural
Sexual activity questionnary
| Study group | Role | What they receive |
|---|---|---|
| Female patients with spondyloarthritis or rheumatoid arthritis | Other | Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up. Receives: Diagnostic Test: Cervical smear; Diagnostic Test: Pregnancy test; Behavioral: Sexual activity questionnary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
Papillomavirus chronic load is defined as a positive HPV test at the end of the study combined with at least 3 positive HPV tests during the 24 months follow-up.
Measured: At the end of the 24 months follow-up.
Secondary outcomes (6)
To determine the prevalence of HPV infections, whatever the type of HPV
Number of patients with a positive HPV test at enrollment
Measured: At enrollment
To determine the incidence of HPV infection in women with a negative HPV test at enrollment.
Number of patients with a negative HPV test at enrollment and having at least one positive HPV test during the 24 months follow-up
Measured: At 24 months.
To determine the clearance of HPV with women with appositive HPV test at enrollment
Number of patients with a positive HPV test at enrollment and having a negative HPV test at the end of the study.
Measured: At 24 months
To evaluate the incidence of cytological abnormalities in women with normal cytology at enrollment according to HPV chronic load and type.
Number of patients with low-grade and high-grade cytological abnormalities during follow-up among those who had normal cytology at enrollment.
Measured: At 24 months.
To determine the evolution (regression, persistence or invasion) of cytological abnormalities in women with abnormal cytology at enrollment and according to HPV chronic load and type.
Number of patients ,with normal cytology at enrollment, whose cervical smear indicates a regression in cytological abnormalities or a persistence of cytological abnormalities or a development of abnormalities into cervical cancer or dysplasia, during the 24 months follow-up.
Measured: At 24 months.
To determine the number of conization according to HPV chronic load and type.
Number of conization
Measured: At 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start9 Jan 2020
- Primary completion9 Jan 2024 (estimated)
- Study completion9 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne COURY-LUCAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713736
- Sponsor's protocol ID
- 69HCL18_0539
- Acronym
- PAPLOR
- Status last verified
- Jun 2021
- First submitted
- 18 Oct 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Papillomavirus Load in Rheumatic Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT03713736
- Acronym / sponsor ID
- PAPLOR / 69HCL18_0539
- Conditions
- Spondyloarthritis, Rhumatoid Arthisis
- Keywords
- HPV infection, Spondyloarthritis, Rhumatoid Arthritis, Cervical smear, cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Jan 2024 (estimated)
- Study completion
- 9 Jan 2024 (estimated)
- First posted
- 22 Oct 2018 (actual)
- 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.
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.
Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.
In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.
Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients with spondyloarthritis or rheumatoid arthritis | Other | Diagnostic Test: Cervical smear, Diagnostic Test: Pregnancy test, Behavioral: Sexual activity questionnaryFemale patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman between 18 and 65 years old
- Patient with rheumatoid arthritis as defined in 2010 ACR/EULAR criteria or with spondyloarthritis as defined in 2009 ASAS criteria
- Patient able to understand the objectives of the study and give documented informed consent
- Patient affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding patient
- Patient with a history of cervical cancer
- Patient under juridical protection
- Patient unable to provide informed consent due to linguistic or psychic impairment
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 |
|---|---|---|
| Cervical smearAlso: HPV testCervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89. | Diagnostic test | Female patients with spondyloarthritis or rheumatoid arthritis |
| Pregnancy testUrinary pregnancy test | Diagnostic test | Female patients with spondyloarthritis or rheumatoid arthritis |
| Sexual activity questionnarySexual activity questionnary | Behavioural | Female patients with spondyloarthritis or rheumatoid arthritis |
Primary outcome
Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
Time frame: At the end of the 24 months follow-up.
Papillomavirus chronic load is defined as a positive HPV test at the end of the study combined with at least 3 positive HPV tests during the 24 months follow-up.
6 secondary outcomes
To determine the prevalence of HPV infections, whatever the type of HPV
Time frame: At enrollment
To determine the incidence of HPV infection in women with a negative HPV test at enrollment.
Time frame: At 24 months.
To determine the clearance of HPV with women with appositive HPV test at enrollment
Time frame: At 24 months
To evaluate the incidence of cytological abnormalities in women with normal cytology at enrollment according to HPV chronic load and type.
Time frame: At 24 months.
To determine the evolution (regression, persistence or invasion) of cytological abnormalities in women with abnormal cytology at enrollment and according to HPV chronic load and type.
Time frame: At 24 months.
To determine the number of conization according to HPV chronic load and type.
Time frame: At 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Fabienne COURY-LUCAS, MD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical smear, Pregnancy test and Sexual activity questionnary in people with Spondyloarthritis and Rhumatoid Arthisis, run by Hospices Civils de Lyon at 3 sites in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne COURY-LUCAS, MD (04 78 86 12 31 ext. +33, fabienne.coury-lucas@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population (time frame: At the end of the 24 months follow-up.). 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 27 Jul 2021.