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Completed

NCT Number: NCT02376478

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

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.

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Key information

About this study

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.

Cervical Papanicolaou (PAP) smears were collected by cytobrush from female patients at the same time.

Blood for determination of serological status was drawn from each patient and peripheral blood mononuclear cells and serum obtained.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

TNF-alpha inhibitors

Drug

therapy for at least 6 months

Other names: Infliximab, adalimumab, etanercept

Alternative/no medication

Drug

therapy for at least 6 months or no therapy

Other names: fumaric acid, mesalazine, sulfasalazine

Alternative/no medication

Other

phototherapy for at least 6 months

Purine/folic acid analogues

Drug

therapy for at least 6 months

Other names: azathioprin, 6-mercaptopurine, methotrexate

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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