Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.
Novartis Investigative Site
Le Mans, Cedex 09, France
Novartis Investigative Site
Limoges, Haute Vienne, France
Novartis Investigative Site
Toulon, Val De Marne, France
Novartis Investigative Site
Amiens, France
Novartis Investigative Site
Antony, France
Novartis Investigative Site
Argenteuil, France
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Brest, France
Novartis Investigative Site
La Rochelle, France
Novartis Investigative Site
Marseille, France
...and 7 more locations
proSPI (s) at Week 16 Compared to Baseline
The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.
Time frame: Week 0 (baseline) to 16 weeks
Changes of saSPI (s) at Week 16 Compared to Baseline
The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition
Time frame: Week 0 (baseline) to 16 weeks
PASI (Psoriasis Area Severity Index) Score
PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)
Time frame: week 0, 16, 52
Correlation Between PASI and proSPI (s)
Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score
Time frame: week 0, 16, 52
proSPI (s, p and i) Over Time
Professional Version of Simplified Psoriasis Index (proSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains : * s for the severity, min =0 and max=50 * p for the psychosocial, min=0 and max=10 * i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure
Time frame: weeks 0, 16, 52
saSPI (s, p and i) Over Time
Self-administered Simplified Psoriasis Index (saSPI) SPI for Simplified Psoriasis Index. SPI is composed of 3 domains : * s for the severity, min =0 and max=50 * p for the psychosocial, min=0 and max=10 * i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure
Time frame: weeks 0, 16, 52
DLQI (Dermatology Life Quality Index) Over Time
DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Time frame: weeks 0, 16, 52
Self-administered PASI (SA-PASI)
self-administered PASI (SA-PASI) score
Time frame: weeks 0, 16, 52
Psoriasis Symptom Diary (PSD) Score
assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling
Time frame: weeks 0, 16, 52
Correlation Between proSPI (for Each Component: s, p and i) and DLQI
Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below
Time frame: weeks 0, 16, 52
Correlation Between proSPI (for Components p and i) and PASI
Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below
Time frame: Over time (from Week 0 to Week 52)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.