Papillomavirus Load in Rheumatic Inflammatory Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 385
- 试验地点
- 6
- 主要终点
- Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prevalence of papillomavirus chronic load in women with rheumatic inflammatory diseases (rheumatoid arthritis and spondyloarthritis), compared to the prevalence in general population
时间窗: At the end of the 24 months follow-up.
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.
次要结局
- 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.)
- To determine the number of conization according to HPV chronic load and type.(At 24 months.)