Regulatory T-cells in Psoriasis Patients as Targets for Therapy

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Burnside House

Aberdeen, AB25 2ZR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dovobet, neotigason, etanercept, adalimumab. infliximab

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

NHS Grampian

Registry information

Official study 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)

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Nov 3, 2010
Registry last updated: Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed