The Impact of Targeted Therapy on Microorganism in Patients With Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01504113
First received: August 3, 2011
Last updated: January 2, 2012
Last verified: July 2011
  Purpose

Background:

Psoriasis is a chronic, immunologically-mediated, inflammatory skin disease and targeted therapies e.g. tumor necrosis factor (TNF)-α and TH-17 antagonists have become increasing important agents in the management of psoriasis. TNF, interleukin-17 (IL-17) and TH-17 play major roles in defense against infection. Large-scaled clinical trials and post-marking surveillance had shown these agents may increase susceptibility to infections. Most studies evaluate the reactivation of tuberculosis but the influence of targeted therapies on the viral infection has not been extensively investigated.

TNF-α has been shown to contribute to the killing of cytomegalovirus (CMV)- and human papillomaviruses (HPV)-infected cells. Additionally, recent studies have shown a high prevalence of HPV DNA in psoriatic skin and increased HPV5 antibodies in patients with psoriasis. The prevalence of HPV in the skin was also affected by therapeutic modalities, such as psoralen-ultraviolet A (PUVA). Several case reports in which CMV, Epstein-Barr virus (EBV) and HPV infection complicated therapy with TNF-α antagonists have been reported. However, the study investigated the effect of TNF-α antagonists and other biologics on reactivation of latent viruses is limited. Only two studies investigated the short-term effect of infliximab on reaction of herpesviruses in patients of rheumatoid arthritis and Crohn's disease. The high prevalence of combination use of immunosuppressants, such as methotrexate alongside with TNF-α antagonists in these patients is different from patients with psoriasis. Additionally, various bacterium and fungi, such as Staphylococcus aureus, Malassezia are associated with provocation and/or exacerbation of psoriasis and recent studies had shown IL-17 is essential for the immune response to common fungus Candida albicans.

Aim:

The aim of this study is to prospectively investigate the effect of target therapies (TNF-α, TH-17 antagonist, IL-17 antagonists, tofacitinib and apremilast) on the activation of viruses, including CMV, EBV and HPV and the impact of biologics on the prevalence of surface colonization of microorganism, including HPV, bacteria and fungi, in patients with psoriasis.

Methods and procedures:

Our project consists of two related study. The first (Study 1), a prospective observational study, included patients with psoriasis who are going to undergo biologics therapy, the viral loads of CMV and EBV, HPV DNA detection in eyebrow hairs and skin scales, and bacterial, fungal cultures from skin scales were performed before the initiation, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. This part of our project is to investigate the dynamic effect of biologics on the microorganisms in patients with psoriasis. The second part (Study 2), a case control study, recruits psoriasis patients who have started target therapies, they receive the sampling of blood, eyebrow hairs and skin scales for CMV, EBV and HPV investigations when they are enrolled. Control group compromised of age-and disease severity-matched psoriasis patients who are not treating with target therapies or other systemic antipsoriatic agents. Comparison of the prevalence of latent virus, virus reactivation, bacteria and fungi skin colonization between psoriasis patients who are treating with and without target therapies is performed. The aim of study 2 was to assess any difference of the status of latent virus or microorganism colonization in skins between psoriasis patients treated with and without target therapies.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Targeted Therapy on Microorganism in Patients With Psoriasis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Changes from baseline in viral loads of human papillomaviruses virus during and after target therapy [ Time Frame: before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies ] [ Designated as safety issue: No ]
    Study 1:The sampling of eyebrow hairs and skin scales before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus and changes from baseline in viral load of human papillomaviruses virus between psoriasis patients who are treating with and without target therapies is performed.

  • Changes from baseline in viral loads of cytomegalovirus during and after target therapy [ Time Frame: before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies ] [ Designated as safety issue: No ]
    Study 1:The sampling of blood before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus, and changes from baseline in viral load of cytomegalovirus between psoriasis patients who are treating with and without target therapies is performed.

  • Changes from baseline in viral loads of Epstein-Barr virus during and after target therapy [ Time Frame: before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies ] [ Designated as safety issue: No ]
    Study 1:The sampling of blood before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus, and changes from baseline in viral load of Epstein-Barr virus between psoriasis patients who are treating with and without target therapies is performed.


Secondary Outcome Measures:
  • Changes from baseline in the prevalence of bacterial and fungal skin colonization during and after target therapy [ Time Frame: before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. ] [ Designated as safety issue: No ]
    Study 1:The sampling of skin scales before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of bacteria and fungi skin colonization between psoriasis patients who are treating with and without target therapies is performed.


Biospecimen Retention:   Samples Without DNA

Serum and skin scales


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study 1 goup
Patients who are planned to receive targeted agents
Study 2 case group
Patients who have received targeted therapy
study 2 control group
Psoriasis patients without target therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We include patients with psoriasis who will receive and who are currently on target therapies,such as TNF-α, TH17,and IL-17 antagonists for psoriasis, in a tertiary referral centre in northern Taiwan (National Taiwan University Hospital (NTUH)) between 2011 and 2015.

Criteria

Study 1

Inclusion Criteria:

  • Clinical diagnosis of psoriasis/psoriatic arthritis and are going o receive target therapies in the near future
  • Age more than 20 years old
  • Will receive target therapies for psoriasis/psoriatic arthritis
  • Willing to receive blood, hair and skin scale sampling

Exclusion Criteria:

  • Pregnancy
  • Not candidates for topical therapies, such as :

Active tuberculosis or HIV, human papillomaviruses, cytomegalovirus infection, Epstein-Barr virus infection Evidence of latent tuberculosis but refuse to receive isoniazid prophylaxis Have malignancy required for chemotherapy or radiotherapy Active uncontrolled hepatitis -Have received phototherapy, systemic immunosuppressants or target therapies within 14, 30, 84 days prior to enrollment, respectively Study 2 (case group)

Inclusion Criteria:

  • Clinical diagnosis of psoriasis/psoriatic arthritis
  • Age more than years old
  • Have received target therapies for more than 3 months
  • willing to receive blood, hair and skin scale sampling

Exclusion Criteria:

  • Pregnancy
  • Not candidates for topical therapies, such as :

Active tuberculosis or HIV, human papillomaviruses, cytomegalovirus infection, Epstein-Barr virus infection Evidence of latent tuberculosis but refuse to receive isoniazid prophylaxis Have malignancy required for chemotherapy or radiotherapy Active uncontrolled hepatitis

-Have received phototherapy, or systemic immunosuppressants within 14 and 30 days prior to enrollment,respectively Study 2 (control group)

Inclusion Criteria:

  • Clinical diagnosis of psoriasis/psoriatic arthritis and are going o receive target therapies in the near future
  • Age more than 20 years old
  • Willing to receive blood, hair and skin scale sampling
  • Without phototherapy, systemic immunosuppressants or target therapies within 84 days prior to enrollment, respectively

Exclusion Criteria:

  • Pregnancy
  • Have received phototherapy within 30 days prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504113

Contacts
Contact: Tsen-Fang Tsai, M.D. 886-2-23562141 tftsai@yahoo.com
Contact: Hsien-Yi Chiu, M.D. 886-2-23123456 ext 29252192 extra.owl@msa.hinet.net

Locations
Taiwan
National Taiwan University Dermatology department Recruiting
Taipei, Taiwan, 100
Contact: Tsen-Fang Tsai, M.D.    886-2-23562141    tftsai@yahoo.com   
Contact: Hsien-Yi Chiu, M.D.    886-2-23123456 ext 29252192    extra.owl@msa.hinet.net   
Principal Investigator: Hsien-yi Chiu, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Tsen-Fang Tsai, M.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01504113     History of Changes
Other Study ID Numbers: 201106079RC
Study First Received: August 3, 2011
Last Updated: January 2, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Target therapy
Biologics
Psoriasis
Latent virus
Human papillomaviruses
Cytomegalovirus
Epstein-Barr virus
Tumor necrosis factor

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 22, 2014