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Regulatory T-cells in Psoriasis Patients as Targets for Therapy

Information source: University of Aberdeen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Dovobet, neotigason, etanercept, adalimumab. infliximab (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aberdeen

Official(s) and/or principal investigator(s):
Anthony D Ormerod, Consultant, Principal Investigator, Affiliation: University of Aberdeen & NHS Grampian

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.

Clinical Details

Official title: 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)

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Clincal-immunological correlation of treatment outcome in psoriasis patients

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Burnside House, Aberdeen AB25 2ZR, United Kingdom
Additional Information

Starting date: June 2010
Last updated: December 2, 2014

Page last updated: August 23, 2015

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