Papillomavirus Load in Rheumatic Inflammatory Diseases

NCT03713736 | Unknown

• 1 other identifier: 69HCL18_0539
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 3

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.

Conditions

Spondyloarthritis; Rhumatoid Arthisis

Keywords

HPV infection; Spondyloarthritis; Rhumatoid Arthritis; Cervical smear; cervical cancer screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  At enrollment

• To determine the incidence of HPV infection in women with a negative HPV test at enrollment.

  At 24 months.

• To determine the clearance of HPV with women with appositive HPV test at enrollment

  At 24 months

• To evaluate the incidence of cytological abnormalities in women with normal cytology at enrollment according to HPV chronic load and type.

  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.

  At 24 months.

Study Arms (1)

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.

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

Interventions

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.

Also known as: HPV test

Female patients with spondyloarthritis or rheumatoid arthritis

Pregnancy test DIAGNOSTIC_TEST

Urinary pregnancy test

Female patients with spondyloarthritis or rheumatoid arthritis

Sexual activity questionnary BEHAVIORAL

Sexual activity questionnary

Female patients with spondyloarthritis or rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

Bron, 69677, France

NOT YET RECRUITING

Hopital Edouard Herriot - service de rhumatologie

Lyon, 69003, France

NOT YET RECRUITING

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69 495, France

RECRUITING

MeSH Terms

Conditions

Spondylarthritis; Papillomavirus Infections

Interventions

Vaginal Smears; Human Papillomavirus DNA Tests; Pregnancy Tests

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques; Molecular Diagnostic Techniques; Genetic Techniques

Study Officials

• Fabienne COURY-LUCAS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne COURY-LUCAS, MD

CONTACT

04 78 86 12 31; fabienne.coury-lucas@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: January 9, 2020
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: July 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)