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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
Help: Registration number
NCT03982394
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
10/06/2019
Date registered
Help: Date registered
11/06/2019
Date last updated
Help: Date last updated
17/11/2025

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)
Additional trial identifiers [1] 0 0
P19-377
Universal Trial Number (UTN)
Trial acronym
VALUE
Related trial records

Health condition
Health condition(s) studied:
Chronic Plaque Psoriasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Participants treated with other approved biological therapies - Treatment decision independently made of study enrollment

Participants treated with Risankizumab - Treatment decision independently made of study enrollment
Description of the comparator or control
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
Healthy volunteers
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
Completed
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
Actual
2/09/2025
Sample size
Target
Accrual to date
Final
2759
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
State/province [2] 0 0
Buenos Aires F.D.
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Argentina
State/province [3] 0 0
CABA
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Austria
State/province [4] 0 0
Styria
Country [5] 0 0
Austria
State/province [5] 0 0
Upper Austria
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Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Austria
State/province [7] 0 0
Vorarlberg
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Austria
State/province [8] 0 0
Hainfeld
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
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Canada
State/province [10] 0 0
British Columbia
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Canada
State/province [11] 0 0
Manitoba
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Canada
State/province [12] 0 0
New Brunswick
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Canada
State/province [13] 0 0
Newfoundland and Labrador
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Canada
State/province [14] 0 0
Ontario
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Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Colombia
State/province [16] 0 0
Antioquia
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Colombia
State/province [17] 0 0
Atlántico
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Colombia
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Cundinamarca
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Colombia
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Barranqulla
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Czechia
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Hradec Kralove
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Ceské Budejovice
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Czechia
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Olomouc
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Prague
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Brittany Region
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France
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France
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Cote-d Or
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France
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France
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Drome
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France
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Finistere
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Isere
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France
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Moselle
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France
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Pays de la Loire Region
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France
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Sarthe
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Lorient
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Hesse
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North Rhine-Westphalia
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Germany
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Holzminden
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L Aquila
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Napoli
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Roma
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Bari
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Brescia
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Ehime
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Japan
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Fukuoka
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Japan
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Japan
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Japan
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Kyoto
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Japan
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Mie-ken
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Japan
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Nagano
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Japan
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Tochigi
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Tokyo
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Estado de Baja California
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Mexico
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Jalisco
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Mexico
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Mexico
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Netherlands
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The Hague
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Poland
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Masovian Voivodeship
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Poland
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Podkarpackie Voivodeship
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Poland
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Pomeranian Voivodeship
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Poland
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Silesian Voivodeship
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Romania
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Bucharest
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Romania
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Ia?i
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Saudi Arabia
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Riyadh Region
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Saudi Arabia
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Mecca
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Saudi Arabia
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Riyadh
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Spain
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Spain
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Pontevedra
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Spain
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Badajoz
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Spain
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Granada
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Spain
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Huelva
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Spain
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León
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Spain
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Lugo
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Spain
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Palencia
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Spain
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Salamanca
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Spain
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Seville
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Spain
State/province [174] 0 0
Zamora
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Spain
State/province [175] 0 0
Zaragoza
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Switzerland
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Canton of Basel-City
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Switzerland
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Canton of Nidwalden
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Switzerland
State/province [178] 0 0
Canton of Zurich
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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
State/province [181] 0 0
Dubai
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United Kingdom
State/province [182] 0 0
Cambridgeshire
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Edinburgh, City of
Country [184] 0 0
United Kingdom
State/province [184] 0 0
England
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Norfolk
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United Kingdom
State/province [186] 0 0
North Yorkshire
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Northamptonshire
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Suffolk
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United Kingdom
State/province [189] 0 0
Surrey
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Wales
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Belfast
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United Kingdom
State/province [192] 0 0
Dudley
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United Kingdom
State/province [193] 0 0
Lyndon
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Manchester
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03982394