A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

Plaque Psoriasis Clinical Trial

— PROSE  

Official title:

An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752776
• Other study ID #: CAIN457A3401
• Secondary ID: 2015-003701-42
• Status: Completed
• Phase: Phase 4
• Start date: March 17, 2016
• Est. completion date: March 28, 2018

Study information

• Verified date: August 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1660
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women aged at least 18 years at time of Screening.

• Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.

• Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Exclusion Criteria:

• Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.

• Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).

• Pregnant or nursing (lactating) women

• Women of child-bearing potential unless they use effective contraception

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Secukinumab
Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Geel	BEL
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Seraing
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Varna
Czechia	Novartis Investigative Site	Plzen
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Praha 5
Czechia	Novartis Investigative Site	Usti nad Labem	Czech Republic
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
France	Novartis Investigative Site	Angers cedex 09
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Argenteuil
France	Novartis Investigative Site	Auxerre
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Boulogne-sur-Mer
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Cannes
France	Novartis Investigative Site	Clermont Ferrand cedex 1
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Grenoble Cedex
France	Novartis Investigative Site	La Rochelle
France	Novartis Investigative Site	Le Mans	Cedex 09
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Martigues
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Pierre Benite Cedex
France	Novartis Investigative Site	Pringy cedex
France	Novartis Investigative Site	Quimper
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Rouen Cedex
France	Novartis Investigative Site	Saint Mande
France	Novartis Investigative Site	St Priest en Jarez Cedex
France	Novartis Investigative Site	Toulon Cedex 9	Val De Marne
France	Novartis Investigative Site	Toulouse Cedex
France	Novartis Investigative Site	Valence Cedex 9
France	Novartis Investigative Site	Valenciennes Cedex
France	Novartis Investigative Site	Vandoeuvre Les Nancy
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Andernach
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bramsche
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Friedrichshafen
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Ibbenbueren
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Ludwigshafen am Rhein
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Pommelsbrunn
Germany	Novartis Investigative Site	Quedlinburg
Germany	Novartis Investigative Site	Recklinghausen
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Simmern
Germany	Novartis Investigative Site	Vechta
Germany	Novartis Investigative Site	Wiesbaden
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Heraklion Crete
Greece	Novartis Investigative Site	Patras
Israel	Novartis Investigative Site	Afula
Israel	Novartis Investigative Site	Be'er Sheva
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Kfar Saba
Israel	Novartis Investigative Site	Petach Tikva
Italy	Novartis Investigative Site	Arezzo	AR
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	San Donato Milanese	MI
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Varese	VA
Latvia	Novartis Investigative Site	Daugavpils	LVA
Latvia	Novartis Investigative Site	Jelgava	LVA
Latvia	Novartis Investigative Site	Riga	LVA
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Ventspils	LVA
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Klaipeda	LTU
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Kielce
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Ossy
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Iasi
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Bardejov	SVK
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Malacky	Slovak Republic
Slovakia	Novartis Investigative Site	Svidnik
Slovakia	Novartis Investigative Site	Zilina
Spain	Novartis Investigative Site	Albacete	Castilla La Mancha
Spain	Novartis Investigative Site	Alcala de Henares	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Almeria	Andalucia
Spain	Novartis Investigative Site	Aranjuez	Madrid
Spain	Novartis Investigative Site	Avila	Castilla Y Leon
Spain	Novartis Investigative Site	Barakaldo	Pais Vasco
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Brena Alta	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Burgos
Spain	Novartis Investigative Site	Elda	Alicante
Spain	Novartis Investigative Site	Ferrol	A Coruna
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
Spain	Novartis Investigative Site	Getafe	Madrid
Spain	Novartis Investigative Site	Granada
Spain	Novartis Investigative Site	Granollers
Spain	Novartis Investigative Site	Guadalajara	Castilla La Mancha
Spain	Novartis Investigative Site	Jerez	Cadiz
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Leganes	Madrid
Spain	Novartis Investigative Site	Lleida	Cataluna
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Mostoles	Madrid, Communidad De
Spain	Novartis Investigative Site	Orense	Galicia
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Talavera de la Reina	Toledo
Spain	Novartis Investigative Site	Tarragona	Catalunya
Spain	Novartis Investigative Site	Terrassa	Catalunya
Spain	Novartis Investigative Site	Toledo	Castilla La Mancha
Spain	Novartis Investigative Site	Torrejon de Ardoz	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla Y Leon
Spain	Novartis Investigative Site	Vigo	Pontevedra
Spain	Novartis Investigative Site	Vitoria	Alava
Spain	Novartis Investigative Site	Zamora	Espana
Spain	Novartis Investigative Site	Zaragoza
United Kingdom	Novartis Investigative Site	Bath
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Burbage	Leicester
United Kingdom	Novartis Investigative Site	Bury Saint Edmonds	Suffolk
United Kingdom	Novartis Investigative Site	Chippenham
United Kingdom	Novartis Investigative Site	Devon
United Kingdom	Novartis Investigative Site	Durham
United Kingdom	Novartis Investigative Site	East Sussex
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Harlow	Essex
United Kingdom	Novartis Investigative Site	Harrow	Middlesex
United Kingdom	Novartis Investigative Site	Lancaster
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Middlesex
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Penzance	Cornwall
United Kingdom	Novartis Investigative Site	Rothwell	GBR
United Kingdom	Novartis Investigative Site	Stoke-on-Trent
United Kingdom	Novartis Investigative Site	Watford
United Kingdom	Novartis Investigative Site	Wellingborough

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Estonia,  France,  Germany,  Greece,  Israel,  Italy,  Latvia,  Lithuania,  Poland,  Portugal,  Romania,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	16 weeks
Secondary	Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	52 weeks
Secondary	Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52	The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.	52 weeks
Secondary	Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52	PASI is a combined assessment of lesion severity & affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 & 100 were defined as participants achieving = 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 16, Week 52
Secondary	Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52	The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health).	Week 16, Week 52
Secondary	Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52	A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").	Week 16, Week 52
Secondary	Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52	The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, "Are you able to..." perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change.	Week 16 and Week 52
Secondary	Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52	Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category.	16 and 52 weeks
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52	Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0—100 scale. Higher summary scores indicate better satisfaction with study drug.	16 and 52 weeks
Secondary	Patient Benefit Index (PBI) at Week 16 and Week 52	The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'.	Week 16 and Week 52