Papillomavirus Load in Rheumatic Inflammatory Diseases (PAPLOR)

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 Overview

• Status: Recruiting
• Conditions: Spondyloarthritis; Rhumatoid Arthisis
• Intervention / Treatment: Diagnostic test: Cervical smear; Diagnostic test: Pregnancy test; Behavioral: Sexual activity questionnary

• Study Type: Interventional
• Enrollment (Anticipated): 385
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabienne COURY-LUCAS, MD; Phone Number: +33 04 78 86 12 31; Email: fabienne.coury-lucas@chu-lyon.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 Names: HPV test; Diagnostic test: Pregnancy test; Urinary pregnancy test; Behavioral: Sexual activity questionnary; Sexual activity questionnary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the 24 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the prevalence of HPV infections, whatever the type of HPV	Number of patients with a positive HPV test at enrollment	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	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.	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.	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.	At 24 months.
To determine the number of conization according to HPV chronic load and type.	Number of conization	At 24 months.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Anticipated): January 9, 2024
• Study Completion (Anticipated): January 9, 2024

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Spondyloarthritis; HPV infection; cervical cancer screening; Rhumatoid Arthritis; Cervical smear
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 69HCL18_0539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No