Papillomavirus Load in Rheumatic Inflammatory Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Papillomavirus Load in Rheumatic Inflammatory Diseases

Conditions
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Spondyloarthritis, Rhumatoid Arthisis

Intervention / Treatment
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* Diagnostic Test: Cervical smear
* Diagnostic Test: Pregnancy test
* Behavioral: Sexual activity questionnary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Female patients with spondyloarthritis or rheumatoid arthritis<br>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<br>* 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.<br>* Other names: HPV test;Diagnostic Test: Pregnancy test<br>* Urinary pregnancy test<br>Behavioral: Sexual activity questionnary<br>* Sexual activity questionnary<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV infection, Spondyloarthritis, Rhumatoid Arthritis, Cervical smear, cervical cancer screening