Papillomavirus Load in Rheumatic Inflammatory Diseases

Spondyloarthritis Clinical Trial

— PAPLOR  

Official title:

Papillomavirus Load in Rheumatic Inflammatory Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713736
• Other study ID #: 69HCL18_0539
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: January 9, 2024

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: Fabienne COURY-LUCAS, MD
• Phone: 04 78 86 12 31
• Email: fabienne.coury-lucas[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 385
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhumatoid Arthisis
• Spondylarthritis
• Spondyloarthritis

Intervention

Diagnostic Test:
• Cervical smear
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.
• Pregnancy test
Urinary pregnancy test

Behavioral:
• Sexual activity questionnary
Sexual activity questionnary

Locations

Country	Name	City	State
France	Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France	Bron
France	Hopital Edouard Herriot - service de rhumatologie	Lyon
France	Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the prevalence of HPV infections, whatever the type of HPV	Number of patients with a positive HPV test at enrollment	At enrollment
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	To determine the number of conization according to HPV chronic load and type.	Number of conization	At 24 months.