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Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis (VALUE)

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ClinicalTrials.gov Identifier: NCT03982394
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease
Chronic Plaque Psoriasis

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Study Type : Observational
Estimated Enrollment : 2700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll adult subjects with moderate to severe plaque psoriasis.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982394


Contacts
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Contact: Stacy Flannery 847.937.9573 stacy.flannery@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03982394     History of Changes
Other Study ID Numbers: P19-377
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Plaque Psoriasis
Risankizumab
Biologics
Psoriasis Vulgaris
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases