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
- Registration Number
- NCT02595970
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
- patient candidates for systemic therapy.
- informed consent.
- previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
- recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Secukinumab Secukinumab Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.
- Primary Outcome Measures
Name Time Method Changes of saSPI (s) at Week 16 Compared to Baseline Week 0 (baseline) to 16 weeks 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
proSPI (s) at Week 16 Compared to Baseline Week 0 (baseline) to 16 weeks 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.
- Secondary Outcome Measures
Name Time Method DLQI (Dermatology Life Quality Index) Over Time weeks 0, 16, 52 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 lifeCorrelation Between PASI and proSPI (s) week 0, 16, 52 Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score
PASI (Psoriasis Area Severity Index) Score week 0, 16, 52 PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)
Self-administered PASI (SA-PASI) weeks 0, 16, 52 self-administered PASI (SA-PASI) score
saSPI (s, p and i) Over Time weeks 0, 16, 52 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 measureproSPI (s, p and i) Over Time weeks 0, 16, 52 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 measurePsoriasis Symptom Diary (PSD) Score weeks 0, 16, 52 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 scalingCorrelation Between proSPI (for Each Component: s, p and i) and DLQI weeks 0, 16, 52 Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below
Correlation Between proSPI (for Components p and i) and PASI Over time (from Week 0 to Week 52) Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below
Trial Locations
- Locations (1)
Novartis Investigative Site
🇫🇷Toulouse Cedex, France