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
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