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临床试验/NCT02376478
NCT02376478已完成不适用

On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection

Medical University of Vienna0 个研究点目标入组 222 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
222
主要终点
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity

研究概览

简要总结

In this prospective, open, controlled, cross-sectional observational study patients with psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included.

Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk (HPV6) and high-risk HPV (HPV16, HPV18) were determined.

详细描述

In this prospective, open, controlled, cross-sectional observational study patients with psoriasis or inflammatory bowel diseases (IBD), who received either Tumor necrosis factor-alpha (TNF-Alpha) inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included.

Patients were assigned to the following subgroups according to their current therapy for ≥ 6 months: i) TNF-alpha inhibitor monotherapy; ii) monotherapy with purine or folic acid analogues, such as azathioprin, 6-mercaptopurine, or methotrexate iii) combination therapy with TNF-alpha blocker plus purine or folic acid analogues; iv) alternate therapy, such as phototherapy, fumaric acid, mesalazine. The last group additionally included patients that were without any therapy.

Information about duration and severity of illness, current and former disease-related medical treatment, smoking habits and sexual history with emphasis on preexisting human papillomavirus (HPV) infection, including anogenital warts or previous abnormal cervical cytology, and HPV vaccination status were obtained for each patient.

Swab samples were taken at one time point from the penile shaft and glans of men, the vulva and cervix in women, and the perianal region of both genders.

Detection of mucosal human papillomavirus DNA in the samples was performed using the FDA-approved Digene Hybrid Capture 2 kit.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants between 18-80 years of age with a history of psoriasis or inflammatory bowel diseases, namely Crohn's disease and ulcerative colitis, and
  • at least 6 month of continuous treatment regimen.

排除标准

  • Pregnant or nursing patients and
  • patients with inherited immune disorders, human immunodeficiency virus infection, invasive malignancies or psychomotor retardation and
  • patients with psoriasis or inflammatory bowel diseases who had received high-dose corticosteroids during the past 6 months.

研究组 & 干预措施

TNF-alpha inhibitors

TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy

干预措施: TNF-alpha inhibitors (Drug)

Purine/folic acid analogues

Purine/folic acid analogues: patients with psoriasis or inflammatory bowel diseases receiving monotherapy with purine or folic acid analogues, such as azathioprin, 6-mercaptopurine, or methotrexate

干预措施: Purine/folic acid analogues (Drug)

Combination therapy

Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues

干预措施: TNF-alpha inhibitors (Drug)

Combination therapy

Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues

干预措施: Purine/folic acid analogues (Drug)

Alternative/no medication

Alternative/no medication: patients with psoriasis or inflammatory bowel diseases receiving alternate therapy, such as phototherapy, fumaric acid, mesalazine, or no medication

干预措施: Alternative/no medication (Other)

结局指标

主要结局

Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reinhard Kirnbauer

Prof. Dr.

Medical University of Vienna

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