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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376478
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Reinhard Kirnbauer, Medical University of Vienna

Brief Summary:

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.


Condition or disease Intervention/treatment
Psoriasis Inflammatory Bowel Diseases Drug: TNF-alpha inhibitors Drug: Alternative/no medication Other: Alternative/no medication Drug: Purine/folic acid analogues

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 222 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
TNF-alpha inhibitors
TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy
Drug: TNF-alpha inhibitors
therapy for at least 6 months
Other Name: Infliximab, adalimumab, etanercept

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
Drug: Purine/folic acid analogues
therapy for at least 6 months
Other Name: azathioprin, 6-mercaptopurine, methotrexate

Combination therapy
Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues
Drug: TNF-alpha inhibitors
therapy for at least 6 months
Other Name: Infliximab, adalimumab, etanercept

Drug: Purine/folic acid analogues
therapy for at least 6 months
Other Name: azathioprin, 6-mercaptopurine, methotrexate

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
Drug: Alternative/no medication
therapy for at least 6 months or no therapy
Other Name: fumaric acid, mesalazine, sulfasalazine

Other: Alternative/no medication
phototherapy for at least 6 months




Primary Outcome Measures :
  1. Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA

Swab samples to detect mucosal HPV DNA using a FDA-approved Assay (Digene Hybrid Capture 2 kit).

Cervical PAP smears were collected by cytobrush. Whole blood to obtain peripheral blood mononuclear cells and serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with psoriasis or inflammatory bowel diseases
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376478


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Reinhard Kirnbauer, MD Medical University of Vienna
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Responsible Party: Reinhard Kirnbauer, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02376478    
Other Study ID Numbers: EK208/2009
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Papillomavirus Infections
Inflammatory Bowel Diseases
Psoriasis
Necrosis
Skin Diseases, Papulosquamous
Skin Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pathologic Processes
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Folic Acid
Sulfasalazine
Adalimumab
Etanercept
Methotrexate
Mercaptopurine
Infliximab
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents