Regulatory T-cells in Psoriasis Patients as Targets for Therapy

December 2, 2014 updated by: University of Aberdeen

Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment With: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF Alpha Therapy (Etanercept, Adalimumab and Infliximab)

The aim of this study is to understand which therapies will suppress effector cells and promote regulatory T cells and To test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors T-cells and/or regulatory cells more able to suppress the effectors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an observational study for the effect of different treatment options of psorisis on regulatory T-cells. Patients in whom a decision to treat with one of the following therapies (Dovobet, neotigason, narrow-band UVB and anti TNF alpha therapy) and agreed to take part in the study will be selected. Allocation of different treatments to patients is not part of the study. We will enroll 40 patients with moderate to severe psoriasis in the age range from 18 to 70. patients must be treatment-free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. females of child bearing potential must be on reliable contraception. Children below 18 years, patients above 70 years, pregnant and lactating patients and immunosuppressed patients are excluded from this study. Blood and tissue samples will be taken before and after treatment. We will also invite 10 patients who are receiving ellipse excisions of naevi, and who known not to have psoriasis, to provide control samples of distal skin beyond the margins required to demonstrate complete removal and control donation of blood.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients and control in this study will be identified and recruited from the department of Dermatology by clinical members of the study team.

Description

Inclusion Criteria:

  • • Male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis.

    • Patients must be treatment free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis.
    • Women of child bearing potential must be on reliable contraception.

    • Patients in whom a decision to treat with one of the following therapies has already been made based on normal clinical care:

      • Dovobet
      • Neotigason
      • Narrow-band UVB
      • Etanercept
      • Adalimumab
      • Infliximab
    • 10 normal controls

Exclusion Criteria:

  • • Children below 18 years and patients over 70 years.

    • Pregnant and lactating patients.
    • Patients who are known to have immunosuppressive disease (e.g. HIV) or on any immunosuppressive therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Betamethasone/Calcipotriol (Dovobet)
patients in whom decision to treat with Dovobet by their dermatologist
Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab
Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks
Acitretin (neotigason)
patients in whom decision to treat with neotigason by their dermatologist
Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab
Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks
narrow-band UVB
patients in whom decision to treat with narrow band UVB by their dermatologist
Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab
Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks
Anti TNF-alpha
patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist
Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab
Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clincal-immunological correlation of treatment outcome in psoriasis patients
Time Frame: 12 months
Primary outcome measures will be the first correlations of treatment outcome in psoriasis patients assessed by PASI score and PGA, with changes in the balance between Treg and effector T cells. This will test whether changes to this balance should be a major target for future therapies. In the short term, the results will also determine whether the balance provides a useful predictive biomarker for response to treatment. It is anticipated that the results will be disseminated through publications in high impact journals and presentation at relevant scientific and clinical meetings
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian

Investigators

  • Principal Investigator: Anthony D Ormerod, Consultant, University of Aberdeen & NHS Grampian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pRGF/009/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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