Papillomavirus Load in Rheumatic Inflammatory Diseases (PAPLOR)

Civil Hospices of Lyon

Status: Unknown

Conditions: Spondyloarthritis; Rhumatoid Arthisis

Treatments: Behavioral: Sexual activity questionnary; Diagnostic Test: Pregnancy test; Diagnostic Test: Cervical smear

Study type: Interventional

Funder types: Other

Identifiers

NCT03713736

69HCL18_0539

Details and patient eligibility

About

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.

Enrollment: 385 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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385 participants in 1 patient group

Female patients with spondyloarthritis or rheumatoid arthritis

Other group

Description:

Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.

Treatment:

Behavioral: Sexual activity questionnary

Diagnostic Test: Pregnancy test

Diagnostic Test: Cervical smear