Papillomavirus Load in Rheumatic Inflammatory Diseases

NCT ID: NCT03713736

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2024-01-09

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.

Detailed Description

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Conditions

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Spondyloarthritis Rhumatoid Arthisis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Female patients with spondyloarthritis or rheumatoid arthritis

Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.

Group Type OTHER

Cervical smear

Intervention Type 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.

Pregnancy test

Intervention Type DIAGNOSTIC_TEST

Urinary pregnancy test

Sexual activity questionnary

Intervention Type BEHAVIORAL

Sexual activity questionnary

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Pregnancy test

Urinary pregnancy test

Intervention Type DIAGNOSTIC_TEST

Sexual activity questionnary

Sexual activity questionnary

Intervention Type BEHAVIORAL

Other Intervention Names

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HPV test

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabienne COURY-LUCAS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Bron, , France

Site Status NOT_YET_RECRUITING

Hopital Edouard Herriot - service de rhumatologie

Lyon, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fabienne COURY-LUCAS, MD

Role: CONTACT

04 78 86 12 31 ext. +33

Facility Contacts

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Gery Lamblin, MD

Role: primary

04.27.85.53.53 ext. +33

Emmanuelle VIGNOT, MD

Role: primary

04.72.11.74.79 ext. +33

Fabienne Coury-lucas, MD

Role: primary

478861231 ext. +33

Other Identifiers

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69HCL18_0539

Identifier Type: -

Identifier Source: org_study_id

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