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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03982394




Registration number
NCT03982394
Ethics application status
Date submitted
10/06/2019
Date registered
11/06/2019
Date last updated
20/06/2024

Titles & IDs
Public title
Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
Scientific title
Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
Secondary ID [1] 0 0
P19-377
Universal Trial Number (UTN)
Trial acronym
VALUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants treated with Risankizumab - Treatment decision independently made of study enrollment

Participants treated with other approved biological therapies - Treatment decision independently made of study enrollment
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
Timepoint [1] 0 0
From Month 4 to 3 years
Primary outcome [2] 0 0
Time to first treatment change
Timepoint [2] 0 0
From Week 0 (Baseline) to first treatment change
Secondary outcome [1] 0 0
Time to first treatment change rate
Timepoint [1] 0 0
At 1 year, 2 year, and 3 year
Secondary outcome [2] 0 0
Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0
Timepoint [2] 0 0
Monthly for up to 3 years
Secondary outcome [3] 0 0
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100
Timepoint [3] 0 0
Monthly for up to 3 years
Secondary outcome [4] 0 0
Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1
Timepoint [4] 0 0
Monthly for up to 3 years
Secondary outcome [5] 0 0
Time to achieve sPGA 0/1 or sPGA 0
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Time to achieve PASI 75, 90,or 100
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval
Timepoint [7] 0 0
At 4 months to 1 year, 2 years, and 3 years
Secondary outcome [8] 0 0
Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval
Timepoint [8] 0 0
At 4 months and 1 year, 2 years, and 3 years
Secondary outcome [9] 0 0
Change in PASI
Timepoint [9] 0 0
From Week 0 to up to 3 years
Secondary outcome [10] 0 0
Change in Body Surface Area (BSA)
Timepoint [10] 0 0
From Week 0 to up to 3 years
Secondary outcome [11] 0 0
Change in Dermatology Quality of Life Index (DLQI) Score
Timepoint [11] 0 0
From Week 0 to up to 3 years
Secondary outcome [12] 0 0
Percentage of participants who achieve DLQI 0/1
Timepoint [12] 0 0
Monthly for up to 3 years
Secondary outcome [13] 0 0
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score
Timepoint [13] 0 0
From Week 0 to up to 3 years

Eligibility
Key inclusion criteria
* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment.
* Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study.
* Participant willing to continue with study documentation after cessation of therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwillingness or inability to comply with study requirements.
* Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2025
Actual
Sample size
Target
2439
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialist /ID# 218158 - Kogarah
Recruitment hospital [2] 0 0
Kingsway Dermatology & Aesthetics /ID# 217616 - Miranda
Recruitment hospital [3] 0 0
Northern Dermatology /ID# 218374 - Chermside
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 217618 - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute Inc /ID# 217619 - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology /ID# 217617 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
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Ciudad Autonoma De Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma Buenos Aires
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Austria
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Oberoesterreich
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Austria
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Steiermark
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Austria
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Vorarlberg
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Austria
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Wien
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Austria
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Hainfeld
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Canada
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Alberta
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British Columbia
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Manitoba
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New Brunswick
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Newfoundland and Labrador
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Ontario
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Quebec
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Netherlands
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Basel-Stadt
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Switzerland
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Nidwalden
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Switzerland
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Zuerich
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Switzerland
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Bern
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United Arab Emirates
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Abu Dhabi
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United Arab Emirates
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Dubai
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United Kingdom
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Cambridgeshire
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United Kingdom
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London, City Of
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Norfolk
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United Kingdom
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Northamptonshire
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Suffolk
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Surrey
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Wales
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Belfast
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Dudley
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Edinburgh
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Lyndon
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Manchester
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Newcastle upon Tyne
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United Kingdom
State/province [206] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.
Trial website
https://clinicaltrials.gov/study/NCT03982394
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03982394