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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03982394
Registration number
NCT03982394
Ethics application status
Date submitted
10/06/2019
Date registered
11/06/2019
Date last updated
14/11/2023
Titles & IDs
Public title
Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
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Scientific title
Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
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Secondary ID [1]
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0
P19-377
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Universal Trial Number (UTN)
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Trial acronym
VALUE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis
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0
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
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Assessment method [1]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
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Timepoint [1]
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From Month 4 to 3 years
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Primary outcome [2]
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Time to first treatment change
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Assessment method [2]
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Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening
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Timepoint [2]
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From Week 0 (Baseline) to first treatment change
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Secondary outcome [1]
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Time to first treatment change rate
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Assessment method [1]
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Time to first treatment change including discontinuation, dose escalation and dose interval shortening.
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Timepoint [1]
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At 1 year, 2 year, and 3 year
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Secondary outcome [2]
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Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0
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Assessment method [2]
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The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit.
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Timepoint [2]
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Monthly for up to 3 years
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Secondary outcome [3]
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Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100
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Assessment method [3]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately.
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Timepoint [3]
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Monthly for up to 3 years
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Secondary outcome [4]
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Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1
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Assessment method [4]
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Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.
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Timepoint [4]
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Monthly for up to 3 years
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Secondary outcome [5]
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Time to achieve sPGA 0/1 or sPGA 0
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Assessment method [5]
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The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Time to achieve PASI 75, 90,or 100
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Assessment method [6]
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PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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At 4 months to 1 year, 2 years, and 3 years
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Secondary outcome [8]
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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
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Assessment method [8]
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Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval.
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Timepoint [8]
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At 4 months and 1 year, 2 years, and 3 years
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Secondary outcome [9]
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Change in PASI
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Assessment method [9]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
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Timepoint [9]
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From Week 0 to up to 3 years
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Secondary outcome [10]
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Change in Body Surface Area (BSA)
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Assessment method [10]
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BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement.
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Timepoint [10]
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From Week 0 to up to 3 years
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Secondary outcome [11]
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Change in Dermatology Quality of Life Index (DLQI) Score
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Assessment method [11]
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The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).
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Timepoint [11]
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From Week 0 to up to 3 years
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Secondary outcome [12]
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Percentage of participants who achieve DLQI 0/1
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Assessment method [12]
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The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired.
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Timepoint [12]
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Monthly for up to 3 years
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Secondary outcome [13]
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Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score
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Assessment method [13]
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The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.
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Timepoint [13]
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From Week 0 to up to 3 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2025
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Actual
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Sample size
Target
2439
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Premier Specialist /ID# 218158 - Kogarah
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Recruitment hospital [2]
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Kingsway Dermatology & Aesthetics /ID# 217616 - Miranda
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Recruitment hospital [3]
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Northern Dermatology /ID# 218374 - Chermside
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Recruitment hospital [4]
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Veracity Clinical Research /ID# 217618 - Woolloongabba
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Recruitment hospital [5]
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Skin Health Institute Inc /ID# 217619 - Carlton
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Recruitment hospital [6]
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Fremantle Dermatology /ID# 217617 - Fremantle
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2228 - Miranda
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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State/province [2]
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Ciuadad 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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Vorarlberg
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Austria
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Wien
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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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Antioquia
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Atlantico
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Distrito Capital De Bogota
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Barranqulla
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Bogotá
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Medellín
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Ceske Budejovice
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Hradec Kralove
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Olomouc
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Germany
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Schwerin
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Germany
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Soest
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Germany
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Germany
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Hungary
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Japan
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Japan
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Japan
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Japan
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Japan
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Mie
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Japan
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Japan
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03982394
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03982394
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