Regulatory T-cells in Psoriasis Patients as Targets for Therapy

NCT ID: NCT01233583

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-09-30

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.

Conditions

Psoriasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Betamethasone/Calcipotriol (Dovobet)

patients in whom decision to treat with Dovobet by their dermatologist

Dovobet, neotigason, etanercept, adalimumab. infliximab

Intervention Type: 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

Acitretin (neotigason)

patients in whom decision to treat with neotigason by their dermatologist

Dovobet, neotigason, etanercept, adalimumab. infliximab

Intervention Type: 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

narrow-band UVB

patients in whom decision to treat with narrow band UVB by their dermatologist

Dovobet, neotigason, etanercept, adalimumab. infliximab

Intervention Type: 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

Anti TNF-alpha

patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist

Dovobet, neotigason, etanercept, adalimumab. infliximab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NHS Grampian

OTHER_GOV

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony D Ormerod, Consultant

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen & NHS Grampian

Locations

Burnside House

Aberdeen, , United Kingdom

Countries

United Kingdom

Other Identifiers

pRGF/009/10

Identifier Type: -

Identifier Source: org_study_id