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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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Caba
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autonoma Buenos Aires
Country [5] 0 0
Austria
State/province [5] 0 0
Oberoesterreich
Country [6] 0 0
Austria
State/province [6] 0 0
Steiermark
Country [7] 0 0
Austria
State/province [7] 0 0
Vorarlberg
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Austria
State/province [9] 0 0
Hainfeld
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
New Brunswick
Country [14] 0 0
Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Colombia
State/province [17] 0 0
Antioquia
Country [18] 0 0
Colombia
State/province [18] 0 0
Atlantico
Country [19] 0 0
Colombia
State/province [19] 0 0
Cundinamarca
Country [20] 0 0
Colombia
State/province [20] 0 0
Barranqulla
Country [21] 0 0
Czechia
State/province [21] 0 0
Ceske Budejovice
Country [22] 0 0
Czechia
State/province [22] 0 0
Hradec Kralove
Country [23] 0 0
Czechia
State/province [23] 0 0
Olomouc
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Czechia
State/province [24] 0 0
Prague
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha
Country [26] 0 0
France
State/province [26] 0 0
Bouches-du-Rhone
Country [27] 0 0
France
State/province [27] 0 0
Bretagne
Country [28] 0 0
France
State/province [28] 0 0
Cote-d Or
Country [29] 0 0
France
State/province [29] 0 0
Deux-Sevres
Country [30] 0 0
France
State/province [30] 0 0
Drome
Country [31] 0 0
France
State/province [31] 0 0
Finistere
Country [32] 0 0
France
State/province [32] 0 0
Hautes-Pyrenees
Country [33] 0 0
France
State/province [33] 0 0
Isere
Country [34] 0 0
France
State/province [34] 0 0
Marne
Country [35] 0 0
France
State/province [35] 0 0
Sarthe
Country [36] 0 0
France
State/province [36] 0 0
Savoie
Country [37] 0 0
France
State/province [37] 0 0
Somme
Country [38] 0 0
France
State/province [38] 0 0
Val-d Oise
Country [39] 0 0
France
State/province [39] 0 0
Yonne
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France
State/province [40] 0 0
Aix En Provence Cedex 1
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France
State/province [41] 0 0
Angers
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France
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Boulogne Billancourt
Country [43] 0 0
France
State/province [43] 0 0
Caen
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France
State/province [44] 0 0
Cannes
Country [45] 0 0
France
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Chalon Sur Saone
Country [46] 0 0
France
State/province [46] 0 0
Epagny Metz Tessy
Country [47] 0 0
France
State/province [47] 0 0
Lorient
Country [48] 0 0
France
State/province [48] 0 0
Saint-Mandé cedex
Country [49] 0 0
France
State/province [49] 0 0
St-Priest-en-Jarez
Country [50] 0 0
France
State/province [50] 0 0
Thionville
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France
State/province [51] 0 0
Toulon CEDEX 9
Country [52] 0 0
Germany
State/province [52] 0 0
Baden-Wuerttemberg
Country [53] 0 0
Germany
State/province [53] 0 0
Bayern
Country [54] 0 0
Germany
State/province [54] 0 0
Niedersachsen
Country [55] 0 0
Germany
State/province [55] 0 0
Rheinland-Pfalz
Country [56] 0 0
Germany
State/province [56] 0 0
Saarland
Country [57] 0 0
Germany
State/province [57] 0 0
Schleswig-Holstein
Country [58] 0 0
Germany
State/province [58] 0 0
Thueringen
Country [59] 0 0
Germany
State/province [59] 0 0
Andernach
Country [60] 0 0
Germany
State/province [60] 0 0
Augsburg
Country [61] 0 0
Germany
State/province [61] 0 0
Bad Kreuznach
Country [62] 0 0
Germany
State/province [62] 0 0
Bad Soden am Taunus
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Germany
State/province [63] 0 0
Bergen
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Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Bielefeld
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Germany
State/province [66] 0 0
Blaubeuren
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Germany
State/province [67] 0 0
Bogen
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Germany
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Borna
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Germany
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Bremen
Country [70] 0 0
Germany
State/province [70] 0 0
Buxtehude
Country [71] 0 0
Germany
State/province [71] 0 0
Darmstadt
Country [72] 0 0
Germany
State/province [72] 0 0
Deggendorf
Country [73] 0 0
Germany
State/province [73] 0 0
Dessau-rosslau
Country [74] 0 0
Germany
State/province [74] 0 0
Dresden
Country [75] 0 0
Germany
State/province [75] 0 0
Dueren
Country [76] 0 0
Germany
State/province [76] 0 0
Essen
Country [77] 0 0
Germany
State/province [77] 0 0
Freising
Country [78] 0 0
Germany
State/province [78] 0 0
Gelsenkirchen
Country [79] 0 0
Germany
State/province [79] 0 0
Gera
Country [80] 0 0
Germany
State/province [80] 0 0
Gernsbach
Country [81] 0 0
Germany
State/province [81] 0 0
Giessen
Country [82] 0 0
Germany
State/province [82] 0 0
Gießen
Country [83] 0 0
Germany
State/province [83] 0 0
Gladbeck
Country [84] 0 0
Germany
State/province [84] 0 0
Hamburg
Country [85] 0 0
Germany
State/province [85] 0 0
Hannover
Country [86] 0 0
Germany
State/province [86] 0 0
Haßfurt
Country [87] 0 0
Germany
State/province [87] 0 0
Heilbad Heiligenstadt
Country [88] 0 0
Germany
State/province [88] 0 0
Holzminden
Country [89] 0 0
Germany
State/province [89] 0 0
Karlsruhe
Country [90] 0 0
Germany
State/province [90] 0 0
Koblenz
Country [91] 0 0
Germany
State/province [91] 0 0
Krefeld
Country [92] 0 0
Germany
State/province [92] 0 0
Kulmbach
Country [93] 0 0
Germany
State/province [93] 0 0
Langenau
Country [94] 0 0
Germany
State/province [94] 0 0
Leipzig
Country [95] 0 0
Germany
State/province [95] 0 0
Loehne
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Germany
State/province [96] 0 0
Luedenscheid
Country [97] 0 0
Germany
State/province [97] 0 0
Magdeburg
Country [98] 0 0
Germany
State/province [98] 0 0
Mainz
Country [99] 0 0
Germany
State/province [99] 0 0
Mönchengladbach
Country [100] 0 0
Germany
State/province [100] 0 0
Neuwied
Country [101] 0 0
Germany
State/province [101] 0 0
Nuremberg
Country [102] 0 0
Germany
State/province [102] 0 0
Osnabrueck
Country [103] 0 0
Germany
State/province [103] 0 0
Remscheid
Country [104] 0 0
Germany
State/province [104] 0 0
Schwelm
Country [105] 0 0
Germany
State/province [105] 0 0
Schwerin
Country [106] 0 0
Germany
State/province [106] 0 0
Soest
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Germany
State/province [107] 0 0
Stuttgart
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Germany
State/province [108] 0 0
Ueberlingen
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Germany
State/province [109] 0 0
Waltershausen
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Germany
State/province [110] 0 0
Werdau
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Germany
State/province [111] 0 0
Wiesbaden
Country [112] 0 0
Germany
State/province [112] 0 0
Witten
Country [113] 0 0
Germany
State/province [113] 0 0
Wolfenbuettel
Country [114] 0 0
Hungary
State/province [114] 0 0
Hajdu-Bihar
Country [115] 0 0
Hungary
State/province [115] 0 0
Vas
Country [116] 0 0
Hungary
State/province [116] 0 0
Pecs
Country [117] 0 0
Hungary
State/province [117] 0 0
Szeged
Country [118] 0 0
Ireland
State/province [118] 0 0
Dublin
Country [119] 0 0
Ireland
State/province [119] 0 0
Cork
Country [120] 0 0
Ireland
State/province [120] 0 0
Limerick
Country [121] 0 0
Italy
State/province [121] 0 0
Ancona
Country [122] 0 0
Italy
State/province [122] 0 0
Catanzaro
Country [123] 0 0
Italy
State/province [123] 0 0
Firenze
Country [124] 0 0
Italy
State/province [124] 0 0
Genova
Country [125] 0 0
Italy
State/province [125] 0 0
L Aquila
Country [126] 0 0
Italy
State/province [126] 0 0
Milano
Country [127] 0 0
Italy
State/province [127] 0 0
Roma
Country [128] 0 0
Italy
State/province [128] 0 0
Umbria
Country [129] 0 0
Italy
State/province [129] 0 0
Bari
Country [130] 0 0
Italy
State/province [130] 0 0
Brescia
Country [131] 0 0
Italy
State/province [131] 0 0
Catania
Country [132] 0 0
Italy
State/province [132] 0 0
Milan
Country [133] 0 0
Italy
State/province [133] 0 0
Napoli
Country [134] 0 0
Italy
State/province [134] 0 0
Padova
Country [135] 0 0
Italy
State/province [135] 0 0
Pisa
Country [136] 0 0
Italy
State/province [136] 0 0
Terracina
Country [137] 0 0
Italy
State/province [137] 0 0
Vicenza
Country [138] 0 0
Japan
State/province [138] 0 0
Aichi
Country [139] 0 0
Japan
State/province [139] 0 0
Ehime
Country [140] 0 0
Japan
State/province [140] 0 0
Fukuoka
Country [141] 0 0
Japan
State/province [141] 0 0
Hokkaido
Country [142] 0 0
Japan
State/province [142] 0 0
Kagawa
Country [143] 0 0
Japan
State/province [143] 0 0
Kagoshima
Country [144] 0 0
Japan
State/province [144] 0 0
Kyoto
Country [145] 0 0
Japan
State/province [145] 0 0
Mie
Country [146] 0 0
Japan
State/province [146] 0 0
Nagano
Country [147] 0 0
Japan
State/province [147] 0 0
Okinawa
Country [148] 0 0
Japan
State/province [148] 0 0
Osaka
Country [149] 0 0
Japan
State/province [149] 0 0
Shizuoka
Country [150] 0 0
Japan
State/province [150] 0 0
Tochigi
Country [151] 0 0
Japan
State/province [151] 0 0
Tokyo
Country [152] 0 0
Mexico
State/province [152] 0 0
Baja California
Country [153] 0 0
Mexico
State/province [153] 0 0
Ciudad De Mexico
Country [154] 0 0
Mexico
State/province [154] 0 0
Jalisco
Country [155] 0 0
Mexico
State/province [155] 0 0
Mexico City
Country [156] 0 0
Mexico
State/province [156] 0 0
Toluca
Country [157] 0 0
Netherlands
State/province [157] 0 0
Gelderland
Country [158] 0 0
Netherlands
State/province [158] 0 0
Limburg
Country [159] 0 0
Netherlands
State/province [159] 0 0
Den Haag
Country [160] 0 0
Netherlands
State/province [160] 0 0
Leeuwarden
Country [161] 0 0
Poland
State/province [161] 0 0
Mazowieckie
Country [162] 0 0
Poland
State/province [162] 0 0
Podkarpackie
Country [163] 0 0
Poland
State/province [163] 0 0
Pomorskie
Country [164] 0 0
Poland
State/province [164] 0 0
Slaskie
Country [165] 0 0
Romania
State/province [165] 0 0
Bucuresti
Country [166] 0 0
Romania
State/province [166] 0 0
Jassi
Country [167] 0 0
Saudi Arabia
State/province [167] 0 0
Ar Riyad
Country [168] 0 0
Saudi Arabia
State/province [168] 0 0
Makkah
Country [169] 0 0
Saudi Arabia
State/province [169] 0 0
Riyadh
Country [170] 0 0
Spain
State/province [170] 0 0
A Coruna
Country [171] 0 0
Spain
State/province [171] 0 0
Balears
Country [172] 0 0
Spain
State/province [172] 0 0
Cadiz
Country [173] 0 0
Spain
State/province [173] 0 0
Illes Balears
Country [174] 0 0
Spain
State/province [174] 0 0
Madrid
Country [175] 0 0
Spain
State/province [175] 0 0
Murcia
Country [176] 0 0
Spain
State/province [176] 0 0
Pontevedra
Country [177] 0 0
Spain
State/province [177] 0 0
Badajoz
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Spain
State/province [178] 0 0
Granada
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Spain
State/province [179] 0 0
Huelva
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Spain
State/province [180] 0 0
Leon
Country [181] 0 0
Spain
State/province [181] 0 0
Lugo
Country [182] 0 0
Spain
State/province [182] 0 0
Palencia
Country [183] 0 0
Spain
State/province [183] 0 0
Salamanca
Country [184] 0 0
Spain
State/province [184] 0 0
Sevilla
Country [185] 0 0
Spain
State/province [185] 0 0
Zamora
Country [186] 0 0
Spain
State/province [186] 0 0
Zaragoza
Country [187] 0 0
Switzerland
State/province [187] 0 0
Basel-Stadt
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Switzerland
State/province [188] 0 0
Nidwalden
Country [189] 0 0
Switzerland
State/province [189] 0 0
Zuerich
Country [190] 0 0
Switzerland
State/province [190] 0 0
Bern
Country [191] 0 0
United Arab Emirates
State/province [191] 0 0
Abu Dhabi
Country [192] 0 0
United Arab Emirates
State/province [192] 0 0
Dubai
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Cambridgeshire
Country [194] 0 0
United Kingdom
State/province [194] 0 0
London, City Of
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Norfolk
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Northamptonshire
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Suffolk
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Surrey
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Wales
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Belfast
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Dudley
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Edinburgh
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Lyndon
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Manchester
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Newcastle upon Tyne
Country [206] 0 0
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
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.