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Completed

NCT Number: NCT03982394

Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emiliano Baccarini Priv Practice /ID# 218581, Lomas de Zamora, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90

    Time frame: From Month 4 to 3 years

    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.

  2. Time to first treatment change

    Time frame: From Week 0 (Baseline) to first treatment change

    Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening

Secondary outcomes

  1. Time to first treatment change rate

    Time frame: At 1 year, 2 year, and 3 year

    Time to first treatment change including discontinuation, dose escalation and dose interval shortening.

  2. Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0

    Time frame: Monthly for up to 3 years

    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.

  3. Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100

    Time frame: Monthly for up to 3 years

    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.

  4. Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1

    Time frame: Monthly for up to 3 years

    Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.

  5. Time to achieve sPGA 0/1 or sPGA 0

    Time frame: Up to 3 years

    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.

  6. Time to achieve PASI 75, 90,or 100

    Time frame: Up to 3 years

    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.

  7. 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

    Time frame: At 4 months to 1 year, 2 years, and 3 years

    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.

  8. 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

    Time frame: At 4 months and 1 year, 2 years, and 3 years

    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.

  9. Change in PASI

    Time frame: From Week 0 to up to 3 years

    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.

  10. Change in Body Surface Area (BSA)

    Time frame: From Week 0 to up to 3 years

    BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement.

  11. Change in Dermatology Quality of Life Index (DLQI) Score

    Time frame: From Week 0 to up to 3 years

    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).

  12. Percentage of participants who achieve DLQI 0/1

    Time frame: Monthly for up to 3 years

    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.

  13. Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score

    Time frame: From Week 0 to up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)

Acronym: VALUE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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