Papillomavirus Load in Rheumatic Inflammatory Diseases (PAPLOR)

• ClinicalTrials.gov Identifier: NCT03713736
• Recruitment Status: Recruiting
• First Posted: October 22, 2018
• Last Update Posted: July 27, 2021
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 385 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Papillomavirus Load in Rheumatic Inflammatory Diseases
• Actual Study Start Date: January 9, 2020
• Estimated Primary Completion Date: January 9, 2024
• Estimated Study Completion Date: January 9, 2024

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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; 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

• Principal Investigator: Fabienne COURY-LUCAS, MD; Hospices Civils de Lyon

More Information

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03713736
• Other Study ID Numbers: 69HCL18_0539
• First Posted: October 22, 2018
• Last Update Posted: July 27, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Spondylarthritis; Musculoskeletal Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Arthritis; Joint Diseases