Papillomavirus Load in Rheumatic Inflammatory Diseases

Hospices Civils de Lyon385 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

385

Conditions

Spondyloarthritis Rhumatoid Arthisis

Interventions

Cervical smearDIAGNOSTIC_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 questionnaryBEHAVIORAL

Sexual activity questionnary

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At the end of the 24 months follow-up.

Secondary Outcomes

To determine the prevalence of HPV infections, whatever the type of HPV

Number of patients with a positive HPV test at enrollment

Time frame: 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

Time frame: 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.

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.

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

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.

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.

Time frame: At 24 months.

To determine the number of conization according to HPV chronic load and type.

Number of conization

Time frame: At 24 months.

Papillomavirus Load in Rheumatic Inflammatory Diseases

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts