Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
NCT04286607
Chronic Plaque Psoriasis
Scottsdale, Arizona, United States
View Trial DetailsNCT Number: NCT03982394
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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Notify Me18 year and older
All sexes
Observational
Emiliano Baccarini Priv Practice /ID# 218581, Lomas de Zamora, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From Week 0 (Baseline) to first treatment change
Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening
Time frame: At 1 year, 2 year, and 3 year
Time to first treatment change including discontinuation, dose escalation and dose interval shortening.
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.
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.
Time frame: Monthly for up to 3 years
Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.
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.
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.
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.
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.
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.
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.
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).
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.
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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Industry
Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
Acronym: VALUE
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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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