PsoriasisNCT02376478
On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
An observational study of Psoriasis and Inflammatory Bowel Diseases, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis, Inflammatory Bowel Diseases
- What is being tested?
- TNF-alpha inhibitors, Alternative/no medication and Purine/folic acid analogues
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with psoriasis or inflammatory bowel diseases
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Psoriasis, Inflammatory Bowel Diseases
- Being tested
- TNF-alpha inhibitors, Alternative/no medication, Purine/folic acid analogues
- Medical subject headings
- Psoriasis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-alpha inhibitorsDrug
Also called Infliximab, adalimumab, etanercept
therapy for at least 6 months
Alternative/no medicationDrug
Also called fumaric acid, mesalazine, sulfasalazine
therapy for at least 6 months or no therapy
Alternative/no medicationOther
phototherapy for at least 6 months
Purine/folic acid analoguesDrug
Also called azathioprin, 6-mercaptopurine, methotrexate
therapy for at least 6 months
| Study group | Role | What they receive |
|---|---|---|
| TNF-alpha inhibitors | TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy Receives: Drug: TNF-alpha inhibitors | |
| 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 Receives: Drug: Purine/folic acid analogues | |
| Combination therapy | Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues Receives: Drug: TNF-alpha inhibitors; Drug: Purine/folic acid analogues | |
| 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 Receives: Drug: Alternative/no medication; Other: Alternative/no medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Kirnbauer, Medical University of Vienna
- Investigators
- Reinhard Kirnbauer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376478
- Sponsor's protocol ID
- EK208/2009
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
- ClinicalTrials.gov ID
- NCT02376478
- Acronym / sponsor ID
- EK208/2009
- Conditions
- Psoriasis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TNF-alpha inhibitors | – | Drug: TNF-alpha inhibitorsTNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy |
| Purine/folic acid analogues | – | Drug: Purine/folic acid analoguesPurine/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 |
| Combination therapy | – | Drug: TNF-alpha inhibitors, Drug: Purine/folic acid analoguesCombination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues |
| Alternative/no medication | – | Drug: Alternative/no medication, Other: Alternative/no medicationAlternative/no medication: patients with psoriasis or inflammatory bowel diseases receiving alternate therapy, such as phototherapy, fumaric acid, mesalazine, or no medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with psoriasis or inflammatory bowel diseases
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF-alpha inhibitorsAlso: Infliximab, adalimumab, etanercepttherapy for at least 6 months | Drug | Combination therapy, TNF-alpha inhibitors |
| Alternative/no medicationAlso: fumaric acid, mesalazine, sulfasalazinetherapy for at least 6 months or no therapy | Drug | Alternative/no medication |
| Alternative/no medicationphototherapy for at least 6 months | Other | Alternative/no medication |
| Purine/folic acid analoguesAlso: azathioprin, 6-mercaptopurine, methotrexatetherapy for at least 6 months | Drug | Combination therapy, Purine/folic acid analogues |
Primary outcome
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhard Kirnbauer, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Inflammatory Bowel Diseases, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.