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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Plaque Psoriasis focused on measuring secukinumab, AIN457, Moderate to severe plaque psoriasis, immune-mediated systemic disease, scaly patches, papules, plaques, itching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab

Arm Description

All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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").
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.
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.
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.
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'.

Full Information

First Posted
February 10, 2016
Last Updated
August 29, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02752776
Brief Title
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 17, 2016 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
secukinumab, AIN457, Moderate to severe plaque psoriasis, immune-mediated systemic disease, scaly patches, papules, plaques, itching

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52
Description
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.
Time Frame
52 weeks
Title
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52
Description
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.
Time Frame
52 weeks
Title
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52
Description
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.
Time Frame
Week 16, Week 52
Title
Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52
Description
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).
Time Frame
Week 16, Week 52
Title
Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52
Description
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").
Time Frame
Week 16, Week 52
Title
Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52
Description
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.
Time Frame
Week 16 and Week 52
Title
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52
Description
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.
Time Frame
16 and 52 weeks
Title
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52
Description
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.
Time Frame
16 and 52 weeks
Title
Patient Benefit Index (PBI) at Week 16 and Week 52
Description
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'.
Time Frame
Week 16 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Geel
State/Province
BEL
ZIP/Postal Code
2440
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Seraing
ZIP/Postal Code
4100
Country
Belgium
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Usti nad Labem
State/Province
Czech Republic
ZIP/Postal Code
400 11
Country
Czechia
Facility Name
Novartis Investigative Site
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Le Mans
State/Province
Cedex 09
ZIP/Postal Code
72037
Country
France
Facility Name
Novartis Investigative Site
City
Toulon Cedex 9
State/Province
Val De Marne
ZIP/Postal Code
83800
Country
France
Facility Name
Novartis Investigative Site
City
Angers cedex 09
ZIP/Postal Code
49933
Country
France
Facility Name
Novartis Investigative Site
City
Antony
ZIP/Postal Code
92160
Country
France
Facility Name
Novartis Investigative Site
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Novartis Investigative Site
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
Novartis Investigative Site
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novartis Investigative Site
City
Boulogne-sur-Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Novartis Investigative Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Novartis Investigative Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Novartis Investigative Site
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
Novartis Investigative Site
City
Clermont Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble Cedex
Country
France
Facility Name
Novartis Investigative Site
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Novartis Investigative Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novartis Investigative Site
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Novartis Investigative Site
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Novartis Investigative Site
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Novartis Investigative Site
City
Pringy cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Novartis Investigative Site
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Novartis Investigative Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Novartis Investigative Site
City
Saint Mande
ZIP/Postal Code
94163
Country
France
Facility Name
Novartis Investigative Site
City
St Priest en Jarez Cedex
ZIP/Postal Code
42277
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex
ZIP/Postal Code
31400
Country
France
Facility Name
Novartis Investigative Site
City
Valence Cedex 9
ZIP/Postal Code
26953
Country
France
Facility Name
Novartis Investigative Site
City
Valenciennes Cedex
ZIP/Postal Code
59322
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68305
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Novartis Investigative Site
City
Andernach
ZIP/Postal Code
56626
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
15831
Country
Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Facility Name
Novartis Investigative Site
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
Novartis Investigative Site
City
Gelsenkirchen
ZIP/Postal Code
45883
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22303
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Ibbenbueren
ZIP/Postal Code
49477
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigshafen am Rhein
ZIP/Postal Code
67063
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Pommelsbrunn
ZIP/Postal Code
91224
Country
Germany
Facility Name
Novartis Investigative Site
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Novartis Investigative Site
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Novartis Investigative Site
City
Simmern
ZIP/Postal Code
55469
Country
Germany
Facility Name
Novartis Investigative Site
City
Vechta
ZIP/Postal Code
49377
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65203
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Novartis Investigative Site
City
Heraklion Crete
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Novartis Investigative Site
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Novartis Investigative Site
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novartis Investigative Site
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
PG
ZIP/Postal Code
06100
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy
Facility Name
Novartis Investigative Site
City
Daugavpils
State/Province
LVA
ZIP/Postal Code
LV-5404
Country
Latvia
Facility Name
Novartis Investigative Site
City
Jelgava
State/Province
LVA
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
State/Province
LVA
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Novartis Investigative Site
City
Ventspils
State/Province
LVA
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1012
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
LT 50161
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Klaipeda
State/Province
LTU
ZIP/Postal Code
92304
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-07195
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Novartis Investigative Site
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Novartis Investigative Site
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-045
Country
Poland
Facility Name
Novartis Investigative Site
City
Ossy
ZIP/Postal Code
42 624
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60 529
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
04141
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1300-000
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200 319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434 502
Country
Portugal
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500366
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700381
Country
Romania
Facility Name
Novartis Investigative Site
City
Malacky
State/Province
Slovak Republic
ZIP/Postal Code
90101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bardejov
State/Province
SVK
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Novartis Investigative Site
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Novartis Investigative Site
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
Facility Name
Novartis Investigative Site
City
Almeria
State/Province
Andalucia
ZIP/Postal Code
04009
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Jerez
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Novartis Investigative Site
City
Albacete
State/Province
Castilla La Mancha
ZIP/Postal Code
02006
Country
Spain
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Castilla La Mancha
ZIP/Postal Code
19002
Country
Spain
Facility Name
Novartis Investigative Site
City
Toledo
State/Province
Castilla La Mancha
ZIP/Postal Code
45071
Country
Spain
Facility Name
Novartis Investigative Site
City
Avila
State/Province
Castilla Y Leon
ZIP/Postal Code
05004
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla Y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Lleida
State/Province
Cataluna
ZIP/Postal Code
25198
Country
Spain
Facility Name
Novartis Investigative Site
City
Tarragona
State/Province
Catalunya
ZIP/Postal Code
43005
Country
Spain
Facility Name
Novartis Investigative Site
City
Terrassa
State/Province
Catalunya
ZIP/Postal Code
08221
Country
Spain
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03550
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Zamora
State/Province
Espana
ZIP/Postal Code
49022
Country
Spain
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Novartis Investigative Site
City
Orense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Facility Name
Novartis Investigative Site
City
Mostoles
State/Province
Madrid, Communidad De
ZIP/Postal Code
28933
Country
Spain
Facility Name
Novartis Investigative Site
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Novartis Investigative Site
City
Aranjuez
State/Province
Madrid
ZIP/Postal Code
28300
Country
Spain
Facility Name
Novartis Investigative Site
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novartis Investigative Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Novartis Investigative Site
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Novartis Investigative Site
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Novartis Investigative Site
City
Barakaldo
State/Province
Pais Vasco
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Novartis Investigative Site
City
Brena Alta
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38712
Country
Spain
Facility Name
Novartis Investigative Site
City
Talavera de la Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Novartis Investigative Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Novartis Investigative Site
City
Granollers
ZIP/Postal Code
08402
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR19 7HX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harlow
State/Province
Essex
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Rothwell
State/Province
GBR
ZIP/Postal Code
NN14 6JQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Burbage
State/Province
Leicester
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bury Saint Edmonds
State/Province
Suffolk
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bath
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bristol
ZIP/Postal Code
BS48 1BZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Chippenham
ZIP/Postal Code
SN14 6GT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Devon
ZIP/Postal Code
EX8 2JF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Middlesex
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Watford
ZIP/Postal Code
WD25 7NL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wellingborough
ZIP/Postal Code
NN8 4RW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
35305260
Citation
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Results Reference
derived
PubMed Identifier
34273904
Citation
da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31.
Results Reference
derived

Learn more about this trial

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

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