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Papillomavirus Load in Rheumatic Inflammatory Diseases (PAPLOR)

Primary Purpose

Spondyloarthritis, Rhumatoid Arthisis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cervical smear
Pregnancy test
Sexual activity questionnary
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spondyloarthritis focused on measuring HPV infection, Spondyloarthritis, Rhumatoid Arthritis, Cervical smear, cervical cancer screening

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
  • Hopital Edouard Herriot - service de rhumatologie
  • Centre Hospitalier Lyon Sud, Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Female patients with spondyloarthritis or rheumatoid arthritis

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determine the prevalence of HPV infections, whatever the type of HPV
Number of patients with a positive HPV test at enrollment
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
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.
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.
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.
To determine the number of conization according to HPV chronic load and type.
Number of conization

Full Information

First Posted
October 18, 2018
Last Updated
July 26, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03713736
Brief Title
Papillomavirus Load in Rheumatic Inflammatory Diseases
Acronym
PAPLOR
Official Title
Papillomavirus Load in Rheumatic Inflammatory Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
January 9, 2024 (Anticipated)
Study Completion Date
January 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Rhumatoid Arthisis
Keywords
HPV infection, Spondyloarthritis, Rhumatoid Arthritis, Cervical smear, cervical cancer screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Female patients with spondyloarthritis or rheumatoid arthritis
Arm Type
Other
Arm Description
Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cervical smear
Other Intervention Name(s)
HPV test
Intervention Description
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
Intervention Name(s)
Pregnancy test
Intervention Description
Urinary pregnancy test
Intervention Type
Behavioral
Intervention Name(s)
Sexual activity questionnary
Intervention Description
Sexual activity questionnary
Primary Outcome Measure Information:
Title
Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
Description
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.
Time Frame
At the end of the 24 months follow-up.
Secondary Outcome Measure Information:
Title
To determine the prevalence of HPV infections, whatever the type of HPV
Description
Number of patients with a positive HPV test at enrollment
Time Frame
At enrollment
Title
To determine the incidence of HPV infection in women with a negative HPV test at enrollment.
Description
Number of patients with a negative HPV test at enrollment and having at least one positive HPV test during the 24 months follow-up
Time Frame
At 24 months.
Title
To determine the clearance of HPV with women with appositive HPV test at enrollment
Description
Number of patients with a positive HPV test at enrollment and having a negative HPV test at the end of the study.
Time Frame
At 24 months
Title
To evaluate the incidence of cytological abnormalities in women with normal cytology at enrollment according to HPV chronic load and type.
Description
Number of patients with low-grade and high-grade cytological abnormalities during follow-up among those who had normal cytology at enrollment.
Time Frame
At 24 months.
Title
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.
Description
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.
Time Frame
At 24 months.
Title
To determine the number of conization according to HPV chronic load and type.
Description
Number of conization
Time Frame
At 24 months.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabienne COURY-LUCAS, MD
Phone
04 78 86 12 31
Ext
+33
Email
fabienne.coury-lucas@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne COURY-LUCAS, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gery Lamblin, MD
Phone
04.27.85.53.53
Ext
+33
Email
gery.lamblin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Gery Lamblin
Facility Name
Hopital Edouard Herriot - service de rhumatologie
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle VIGNOT, MD
Phone
04.72.11.74.79
Ext
+33
Email
emmanuelle.vignot@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Vignot, MD
Facility Name
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69 495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne Coury-lucas, MD
Phone
478861231
Ext
+33
Email
fabienne.coury-lucas@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Muriel PIPERNO, MD
First Name & Middle Initial & Last Name & Degree
Fabienne COURY-LUCAS, MD
First Name & Middle Initial & Last Name & Degree
Jean-Paul LARBRE, MD
First Name & Middle Initial & Last Name & Degree
Nathalie HOEN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Papillomavirus Load in Rheumatic Inflammatory Diseases

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