Clinical trial NCT03713736: Papillomavirus Load in Rheumatic Inflammatory Diseases
Official title: Papillomavirus Load in Rheumatic Inflammatory Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spondyloarthritis
Rhumatoid Arthisis
Keywords: HPV infection
Spondyloarthritis
Rhumatoid Arthritis
Cervical smear
cervical cancer screening
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 385
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
timeFrame: At the end of the 24 months follow-up.
Secondary outcomes:
measure: To determine the prevalence of HPV infections, whatever the type of HPV
timeFrame: At enrollment
measure: To determine the incidence of HPV infection in women with a negative HPV test at enrollment.
timeFrame: At 24 months.
measure: To determine the clearance of HPV with women with appositive HPV test at enrollment
timeFrame: At 24 months
measure: To evaluate the incidence of cytological abnormalities in women with normal cytology at enrollment according to HPV chronic load and type.
timeFrame: At 24 months.
measure: 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.
timeFrame: At 24 months.
measure: To determine the number of conization according to HPV chronic load and type.
timeFrame: At 24 months.
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
city: Lyon
country: France
facility: Hopital Edouard Herriot - service de rhumatologie
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabienne COURY-LUCAS, MD
role: PRINCIPAL_INVESTIGATOR
References: