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Trial registered on ANZCTR


Registration number
ACTRN12613000419763
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
15/04/2013
Date last updated
16/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study to assess the effect of adalimumab on cardiovascular biomarkers in participants with severe chronic plaque psoriasis
Scientific title
An open-label, prospective pilot study evaluating the effect of adalimumab on endothelial function and on cardiovascular biomarkers in severe chronic plaque psoriasis patients eligible for biologic treatment in Australia
Secondary ID [1] 282247 0
Nil
Universal Trial Number (UTN)
U1111-1141-4784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic plaque psoriasis 288773 0
Condition category
Condition code
Skin 289125 289125 0 0
Dermatological conditions
Inflammatory and Immune System 289226 289226 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient who are deemed eligible for adalimumab according to PBS Australia biologics criteria will be administered with 80mg adalimumab subcutaneously at week 0, 40mg at week 1 and 40 mg subcutaneously every other week. Patients are reviewed at week 6, 12 and every 3 months thereafter if they are on treatment with adalimumab. A PASI (Psoriasis assessment severity index) is performed at each visit to monitor response. Patients will remain in treatment indefinitely if they respond to adalimumab.
Intervention code [1] 286864 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289240 0
To determine whether there are potential beneficial effects of TNF-inhibition on endothelial function using an EndoPAT
Timepoint [1] 289240 0
12 weeks post-starting adalimumab
Secondary outcome [1] 302091 0
To determine whether there are beneficial effects of TNF-inhibition on known risk factors such as lipids, insulin resistance and blood pressure with blood tests and sphygmomanometer.
Timepoint [1] 302091 0
12 weeks post-starting adalimumab
Secondary outcome [2] 302282 0
To determine whether ApoB and ApoA-1 testing if a better indicator of cardiovascular abnormalities than the standard measurement of HDL and LDL with blood tests.
Timepoint [2] 302282 0
12 weeks post-starting adalimumab
Secondary outcome [3] 302283 0
To determine whether the psoriasis activity (PASI score) duration correlates with endothelial function impairment using EndoPAT.
Timepoint [3] 302283 0
12 weeks post-starting adalimumab

Eligibility
Key inclusion criteria
Patient who has had severe chronic plaque psoriasis for at least 6 months with no previous exposure to biologics, and is eligible for biologics as per Australian PBS requirements and has been selected to start adalimumab by a dermatologist
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not starting on adalimumab as their first biological agent or has had prior biologic treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6655 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 287014 0
Commercial sector/Industry
Name [1] 287014 0
AbbVie Pty Ltd
Country [1] 287014 0
Australia
Primary sponsor type
Individual
Name
Dr Anna Braue
Address
Dermatology Unit, The Royal Melbourne Hospital
Grattan Street,
Parkvilled
VIC 3050
Country
Australia
Secondary sponsor category [1] 285797 0
None
Name [1] 285797 0
Address [1] 285797 0
Country [1] 285797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289054 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 289054 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [1] 289054 0
Australia
Date submitted for ethics approval [1] 289054 0
Approval date [1] 289054 0
17/10/2012
Ethics approval number [1] 289054 0
2012.097

Summary
Brief summary
This is a prospective, single-centre study of adalimumab in participants with severe chronic plaque psoriasis and eligible for biologic treatment as per Australian Pharmaceutical benefits Scheme (PBS) criteria. We hope this study confirms our hypothesis that patients treated with adalimumab for a 12 weeks period will have improved endothelial function compared to pre-treatment score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38998 0
Dr Anna Braue
Address 38998 0
The Royal Melbourne Hospital
Parkville
VICTORIA 3050
Country 38998 0
Australia
Phone 38998 0
+61393424531
Fax 38998 0
Email 38998 0
[email protected]
Contact person for public queries
Name 38999 0
Stephanie Tan
Address 38999 0
The Royal Melbourne Hospital
Parkville
VICTORIA 3050
Country 38999 0
Australia
Phone 38999 0
+61393424531
Fax 38999 0
Email 38999 0
[email protected]
Contact person for scientific queries
Name 39000 0
Stephanie Tan
Address 39000 0
The Royal Melbourne Hospital
Parkville
VICTORIA 3050
Country 39000 0
Australia
Phone 39000 0
+61393424531
Fax 39000 0
Email 39000 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.