PsoriasisNCT01233583
Regulatory T-cells in Psoriasis Patients as Targets for Therapy
An observational study of Psoriasis, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Dovobet, neotigason, etanercept, adalimumab. infliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- • 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
Show all 11Show fewer
- Narrow-band UVB
- Etanercept
- Adalimumab
- Infliximab
- 10 normal controls
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- Dovobet, neotigason, etanercept, adalimumab. infliximab
- Keywords
- Regulatory T-cells, psoriasis, IL-10.
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dovobet, neotigason, etanercept, adalimumab. infliximabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone/Calcipotriol (Dovobet) | patients in whom decision to treat with Dovobet by their dermatologist Receives: Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab | |
| Acitretin (neotigason) | patients in whom decision to treat with neotigason by their dermatologist Receives: Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab | |
| narrow-band UVB | patients in whom decision to treat with narrow band UVB by their dermatologist Receives: Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab | |
| Anti TNF-alpha | patients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist Receives: Drug: Dovobet, neotigason, etanercept, adalimumab. infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clincal-immunological correlation of treatment outcome in psoriasis patients
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Anthony D Ormerod, Consultant, Principal investigator, University of Aberdeen & NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233583
- Sponsor's protocol ID
- pRGF/009/10
- Status last verified
- Dec 2014
- First submitted
- 2 Nov 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01233583
- Acronym / sponsor ID
- pRGF/009/10
- Conditions
- Psoriasis
- Keywords
- Regulatory T-cells, psoriasis, IL-10.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Jun 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Betamethasone/Calcipotriol (Dovobet) | – | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximabpatients in whom decision to treat with Dovobet by their dermatologist |
| Acitretin (neotigason) | – | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximabpatients in whom decision to treat with neotigason by their dermatologist |
| narrow-band UVB | – | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximabpatients in whom decision to treat with narrow band UVB by their dermatologist |
| Anti TNF-alpha | – | Drug: Dovobet, neotigason, etanercept, adalimumab. infliximabpatients in whom decision to treat with anti TNF-alpha(adalimumab-etanercept-infliximab) by their dermatologist |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- • Male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis.
Key exclusion criteria (3 listed)
- • Children below 18 years and patients over 70 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dovobet, neotigason, etanercept, adalimumab. infliximabDovobet 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 | Drug | Acitretin (neotigason), Anti TNF-alpha, Betamethasone/Calcipotriol (Dovobet), narrow-band UVB |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony D Ormerod, Consultant principal investigator
University of Aberdeen & NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clincal-immunological correlation of treatment outcome in psoriasis patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.