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Papillomavirus Load in Rheumatic Inflammatory Diseases (PAPLOR)

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ClinicalTrials.gov Identifier: NCT03713736
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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 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.


Condition or disease Intervention/treatment Phase
Spondyloarthritis Rhumatoid Arthisis Diagnostic Test: Cervical smear Diagnostic Test: Pregnancy test Behavioral: Sexual activity questionnary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 385 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Papillomavirus Load in Rheumatic Inflammatory Diseases
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Female patients with spondyloarthritis or rheumatoid arthritis
Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.
Diagnostic Test: Cervical smear
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.
Other Name: HPV test

Diagnostic Test: Pregnancy test
Urinary pregnancy test

Behavioral: Sexual activity questionnary
Sexual activity questionnary




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To determine the prevalence of HPV infections, whatever the type of HPV [ Time Frame: At enrollment ]
    Number of patients with a positive HPV test at enrollment

  2. To determine the incidence of HPV infection in women with a negative HPV test at enrollment. [ Time Frame: At 24 months. ]
    Number of patients with a negative HPV test at enrollment and having at least one positive HPV test during the 24 months follow-up

  3. To determine the clearance of HPV with women with appositive HPV test at enrollment [ Time Frame: At 24 months ]
    Number of patients with a positive HPV test at enrollment and having a negative HPV test at the end of the study.

  4. 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. ]
    Number of patients with low-grade and high-grade cytological abnormalities during follow-up among those who had normal cytology at enrollment.

  5. 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. ]
    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.

  6. To determine the number of conization according to HPV chronic load and type. [ Time Frame: At 24 months. ]
    Number of conization



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713736


Contacts
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Contact: Fabienne COURY-LUCAS, MD 04 78 86 12 31 ext +33 fabienne.coury-lucas@chu-lyon.fr

Locations
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France
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France Not yet recruiting
Bron, France, 69677
Contact: Gery Lamblin, MD    04.27.85.53.53 ext +33    gery.lamblin@chu-lyon.fr   
Principal Investigator: Gery Lamblin         
Hopital Edouard Herriot - service de rhumatologie Not yet recruiting
Lyon, France, 69003
Contact: Emmanuelle VIGNOT, MD    04.72.11.74.79 ext +33    emmanuelle.vignot@chu-lyon.fr   
Principal Investigator: Emmanuelle Vignot, MD         
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Not yet recruiting
Pierre-Bénite, France, 69 495
Contact: Fabienne Coury-lucas, MD    478861231 ext +33    fabienne.coury-lucas@chu-lyon.fr   
Sub-Investigator: Muriel PIPERNO, MD         
Principal Investigator: Fabienne COURY-LUCAS, MD         
Sub-Investigator: Jean-Paul LARBRE, MD         
Sub-Investigator: Nathalie HOEN, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Fabienne COURY-LUCAS, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03713736     History of Changes
Other Study ID Numbers: 69HCL18_0539
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
HPV infection
Spondyloarthritis
Rhumatoid Arthritis
Cervical smear
cervical cancer screening

Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases