Regulatory T-cells in Psoriasis Patients as Targets for Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Aberdeen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NHS Grampian
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01233583
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Psoriasis
Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Clincal-immunological correlation of treatment outcome in psoriasis patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Whole Blood Skin biopsy


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Betamethasone/Calcipotriol (Dovobet)
patients in whom decision to treat with Dovobet by their dermatologist
Drug: 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
Acitretin (neotigason)
patients in whom decision to treat with neotigason by their dermatologist
Drug: 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
narrow-band UVB
patients in whom decision to treat with narrow band UVB by their dermatologist
Drug: 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
Anti TNF-alpha
patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist
Drug: 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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients and control in this study will be identified and recruited from the department of Dermatology by clinical members of the study team.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233583

Contacts
Contact: Anthony D Ormerod, Consultant 01224 553955 a.d.ormerod@abdn.ac.uk

Locations
United Kingdom
Burnside House Recruiting
Aberdeen, United Kingdom, AB25 2ZR
Contact: Linda G Lawson, Research nurse    01224 552906    lindag.lawson@nhs.net   
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
Principal Investigator: Anthony D Ormerod, Consultant University of Aberdeen & NHS Grampian
  More Information

No publications provided

Responsible Party: Dr. Gail Holland, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01233583     History of Changes
Other Study ID Numbers: pRGF/009/10
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Aberdeen:
Regulatory T-cells, psoriasis, IL-10.

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Infliximab
Adalimumab
Betamethasone
Acitretin
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014