Clinical Trial Results:
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 α Therapy (Etanercept, Adalimumab and Infliximab)
Summary
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EudraCT number |
2010-019129-32 |
Trial protocol |
GB |
Global end of trial date |
30 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2018
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First version publication date |
24 Aug 2018
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Other versions |
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Summary report(s) |
Publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
pRGF/009/10
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01233583 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Aberdeen
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Sponsor organisation address |
Research Governance, Foresterhill House Annexe, Aberdeen, United Kingdom,
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Public contact |
Robert N. Baker, University of Aberdeen, 01224 554362, researchgovernance@abdn.ac.uk
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Scientific contact |
Robert N. Barker, University of Aberdeen, 01224 554362, researchgovernance@abdn.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Oct 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Oct 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1) The objective is to test whether patient's response to conventional currently used psoriasis treatment, used in normal clinical practice is determined by regulatory T cells (cells which control the inflammtory response in psoriasis).
2) This will be acheived for each of 4 routinely used types of psoriasis therapy (topical calcipotriol/betamethasone combination, oral retinoid, NBUVB and anti-TNF α therapy) by taking blood tests and a skin sample before treatment and after 6weeks
3) The analysis of samples for Treg and Teffector cells.
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Protection of trial subjects |
This study was approved by the North of Scotland Research Ethics Committee and the Medicines and Healthcare Products Regulatory Agency according to the Declaration of Helsinki protocols. All participants signed written informed consent.
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Background therapy |
The imbalance between CD4+ T effector cells, particularly the T helper (Th) 17 sub-set, and regulatory T cells (Tregs) is key to the development of psoriatic lesions, and therefore a novel therapeutic target. | ||
Evidence for comparator |
This study quantifies in patients the effects of three commonly used psoriasis treatment modalities on the TH1, Th2, Th17 and Treg subsets, and tests whether any changes correlate with clinical response. | ||
Actual start date of recruitment |
24 Jun 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
34
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
34
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients will be identified and recruited from the department of Dermatology by clinical members of the study team. Posters will be displayed in GP surgeries, the dermatology clinic, on television screens in medical sciences building on the Foresterhill site to speed up the rate of recruitment in Dovobet arm. | ||||||||||||
Pre-assignment
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Screening details |
Participants who response to the poster and are identified as suitable and interested in taking part will receive the patient information sheet and be notified to the study team who will arrange for the consent to be taken. Patients will receive treatments as part of their routine clinical care. | ||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
Standard routine care
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dovobet | ||||||||||||
Arm description |
One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). | ||||||||||||
Arm type |
Standard Clinical Treatment | ||||||||||||
Investigational medicinal product name |
Calcipottriol/betamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Topical use
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Dosage and administration details |
Dovobet ointment should be applied to the affected area once daily.
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Arm title
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Adalimumab | ||||||||||||
Arm description |
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. | ||||||||||||
Arm type |
Standard Clinical Treatment | ||||||||||||
Investigational medicinal product name |
Humira
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
20mg solution for injection is pre-filled syringe.
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Arm title
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NB-UVB | ||||||||||||
Arm description |
Narrowband NB-UVB phototherapy | ||||||||||||
Arm type |
Standard Clinical Treatment | ||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
A breakdown of the age groups recruited are not available, only the total recruitment figure. | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dovobet
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Reporting group description |
One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). | ||
Reporting group title |
Adalimumab
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Reporting group description |
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. | ||
Reporting group title |
NB-UVB
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Reporting group description |
Narrowband NB-UVB phototherapy |
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End point title |
Clinical-immunological correlation | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Before and after receiving treatment.
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Statistical analysis title |
Two-tailed paired t-test | ||||||||||||
Statistical analysis description |
Statistical analysis were carried out using Prism GraphPad 5 for windows, V5.02 2008. A two-tailed paired t-test was used to compare proportions of cells in lesional vs nonlesional skin, blood of patients.
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Comparison groups |
Adalimumab v NB-UVB v Dovobet
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Spearman correlation | ||||||||||||
Confidence interval |
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Notes [1] - The Mann-Whitney U-test was used to compare the proportions of cells between blood and skin of patients and healthy controls. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Once the investigator becomes aware that a SAE has occurred in a study participant, they will report it via Yellow Card Scheme to, REC, R&D and to the sponsor as per the University of Aberdeen SOP.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
N/A | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Not documented in final report. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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30 Mar 2012 |
AM03 – To extend the study end date; increase the number of participants; additional advertising to increase recruitment in the Dovobet arm. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |