Regulatory T-cells in Psoriasis Patients as Targets for Therapy

Completed

• Conditions: Psoriasis
• Interventions: Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab

• Registration Number: NCT01233583
• Lead Sponsor: University of Aberdeen

Brief Summary

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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Betamethasone/Calcipotriol (Dovobet)	Dovobet, neotigason, etanercept, adalimumab. infliximab	patients in whom decision to treat with Dovobet by their dermatologist
Anti TNF-alpha	Dovobet, neotigason, etanercept, adalimumab. infliximab	patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist
Acitretin (neotigason)	Dovobet, neotigason, etanercept, adalimumab. infliximab	patients in whom decision to treat with neotigason by their dermatologist
narrow-band UVB	Dovobet, neotigason, etanercept, adalimumab. infliximab	patients in whom decision to treat with narrow band UVB by their dermatologist

Primary Outcome Measures

Name	Time	Method
Clincal-immunological correlation of treatment outcome in psoriasis patients	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

Trial Locations

Locations (1)

Burnside House; 🇬🇧 Aberdeen, United Kingdom