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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female patients with spondyloarthritis or rheumatoid arthritis | Other | Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical smear | Diagnostic 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabienne COURY-LUCAS, MD | Contact | 04 78 86 12 31 | +33 | fabienne.coury-lucas@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fabienne COURY-LUCAS, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France | Not yet recruiting | Bron | 69677 | France |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014626 | Vaginal Smears |
| D061809 | Human Papillomavirus DNA Tests |
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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|
|
| Pregnancy test | Diagnostic Test | Urinary pregnancy test |
|
| Sexual activity questionnary | Behavioral | Sexual activity questionnary |
|
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. |
| Hopital Edouard Herriot - service de rhumatologie | Not yet recruiting | Lyon | 69003 | France |
|
| Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Recruiting | Pierre-BĂ©nite | 69 495 | France |
|
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D005821 | Genetic Techniques |