Efficacy and Safety of Subcutaneous Secukinumab (AIN457)... | NCT01406938 | Trialant
NCT01406938
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
May 19, 2015Estimated
Enrollment
967Actual
Phase
Phase 3
Conditions
Moderate to Severe Plaque-type Psoriasis
Interventions
AIN457 150mg
AIN457 300mg
Countries
United States
Austria
Bulgaria
Canada
Czechia
France
Germany
India
Italy
Japan
Poland
Singapore
Slovakia
Switzerland
United Kingdom
Vietnam
Protocol Section
Identification Module
NCT ID
NCT01406938
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2304
Secondary IDs
ID
Type
Description
Link
2011-000767-27
EudraCT Number
Brief Title
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Official Title
A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Acronym
SCULPTURE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Apr 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2011
Primary Completion Date
May 2013Actual
Completion Date
May 2013Actual
First Submitted Date
Jul 12, 2011
First Submission Date that Met QC Criteria
Jul 29, 2011
First Posted Date
Aug 1, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2015
Results First Submitted that Met QC Criteria
Apr 30, 2015
Results First Posted Date
May 19, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 30, 2015
Last Update Posted Date
May 19, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Moderate to Severe Plaque-type Psoriasis
Keywords
Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to Severe Plaque-type Psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
967Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AIN457150 mg- Induction period Only(IPO)
Experimental
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 150 mg - Fixed Interval (FI)
AIN457 150 mg- Start of relapse (SoR)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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)
Week 40 , week 52
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
Severity of disease meeting all of the following three criteria:
PASI score of 12 or greater,
Investigator's Global Assessment (IGA) score of 3 or greater
Total body surface area (BSA) affected of 10% or greater.
Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria:
Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
Current drug-induced psoriasis.
Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
Hematological abnormalities.
History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply.
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.
966 patients randomized to two groups, induction secukinumab 150 mg or secukinumab 300 mg. Most randomized patients, 928/966 completed the 12-week induction period. 928 completed the induction period, a total of 843 were re-randomized to the maintenance period to either fixed interval dosing or start of relapse dosing at their respective dose level
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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
Baseline, week 2, 4, 6, 8, 12
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Baseline to week 2, 4, 8, 12
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Baseline to week 2, 4, 8, 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Baseline to week 2, 4, 6, 8, 12
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
Median Time to Relapse (Weeks) From Week 12.
Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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). A negative mean percentage change indicates improvement
Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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 12
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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 52
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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, 20, 24,28,32,36,40,44,48,and Week 52
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
week 16, 20, 24,28,32,36,40,44,48,and Week 52
Number of Participants Developing Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60
Baseline, weeks 12, 24, 52 and 60
Pasadena
California
91105
United States
Novartis Investigative Site
Sacramento
California
95817
United States
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San Francisco
California
94118
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Jacksonville
Florida
32204
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Jacksonville
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32216
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Miami
Florida
33136
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Naples
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34119
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South Miami
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33143
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West Palm Beach
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33409
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Atlanta
Georgia
30342
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Champaign
Illinois
61820
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Skokie
Illinois
60077
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Springfield
Illinois
62703
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Indianapolis
Indiana
46256
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Overland Park
Kansas
66215
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Owensboro
Kentucky
42301
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Boston
Massachusetts
02111
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Fridley
Minnesota
55432
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St Louis
Missouri
63117
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Henderson
Nevada
89052
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Las Vegas
Nevada
89119
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Verona
New Jersey
07044
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Greensboro
North Carolina
27401
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High Point
North Carolina
27262
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Winston-Salem
North Carolina
27103
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Anderson
South Carolina
29621
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Greer
South Carolina
29651
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Goodlettsville
Tennessee
37072-2301
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Dallas
Texas
75230
United States
Novartis Investigative Site
Dallas
Texas
75231
United States
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San Antonio
Texas
78229
United States
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Salt Lake City
Utah
84124
United States
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Wels
Austria
4600
Austria
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Graz
A-8036
Austria
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Linz
A-4010
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Vienna
A-1220
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Sofia
Bulgaria
1606
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Pleven
5800
Bulgaria
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Sofia
1231
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Sofia
1404
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Sofia
1431
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Varna
9010
Bulgaria
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Barrie
Ontario
L4M 6L2
Canada
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Oakville
Ontario
L6J 7W5
Canada
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Waterloo
Ontario
N2J 1C4
Canada
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Windsor
Ontario
N8W 1E6
Canada
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Montreal
Quebec
H2K 4L5
Canada
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Brno-Bohunice
Czech Republic
625 00
Czechia
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Hradec Králové
CZE
500 05
Czechia
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Prague
CZE
180 81
Czechia
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České Budějovice
370 01
Czechia
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Nový Jičín
741 01
Czechia
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Prague
100 34
Czechia
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Toulouse
France
31059
France
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Antony
92160
France
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Nice
06202
France
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Pierre-Benite Cédex
F-69495
France
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Rouen
76031
France
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Münster
Germany
48149
Germany
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Bad Wildbad
75323
Germany
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Bochum
44803
Germany
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Buchholz I. D. Nordheide
21244
Germany
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Cologne
50937
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Dippoldiswalde-Schmiedeberg
01744
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Duisburg
47167
Germany
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Düsseldorf
40225
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Essen
45147
Germany
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Frankfurt
60590
Germany
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Freiburg im Breisgau
79104
Germany
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Hamburg
20246
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Hamburg
22143
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Hamburg
22391
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Hanover
30625
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Kiel
24105
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Lübeck
23538
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Mahlow
15831
Germany
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Mainz
55131
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Mannheim
68167
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Pommelsbrunn
91224
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Wuppertal
42103
Germany
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Hyderabad
Andhra Pradesh
500 058
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Secunderabad
Andhra Pradesh
500 094
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Bangalore
Karnataka
560054
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Mangalore
Karnataka
575 004
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Mumbai
Maharashtra
400 008
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Nagpur
Maharashtra
440 010
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Nagpur
Maharashtra
440013
India
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Nagpur
Maharashtra
India
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Nashik
Maharashtra
India
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Roma
RM
00133
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RM
00144
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53100
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37126
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Aichi-ken
467-8602
Japan
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Chiba
292-8535
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Fukuoka
815-8588
Japan
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Kitakyushu
Fukuoka
800-0296
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Maebashi
Gunma
371-8511
Japan
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Asahikawa
Hokkaido
078-8510
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Sapporo
Hokkaido
060-0033
Japan
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Osaka
Osaka
550-0012
Japan
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Shimotsuke
Tochigi
329-0498
Japan
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Chiyoda-ku
Tokyo
102-8798
Japan
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Hachiōji
Tokyo
193-0998
Japan
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Itabashi-ku
Tokyo
173-8610
Japan
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Minato-ku
Tokyo
105-8471
Japan
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Shinjuku-ku
Tokyo
160-0023
Japan
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Shinjuku-ku
Tokyo
160-8582
Japan
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Lodz
90-265
Poland
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Poznan
60-539
Poland
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Wroclaw
50-368
Poland
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Singapore
Singapore
119074
Singapore
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Singapore
Singapore
308205
Singapore
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Košice
Slovak Republic
040 15
Slovakia
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Košice
Slovakia
04011
Slovakia
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Poprad
Slovakia
05845
Slovakia
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Svidník
Slovakia
089 01
Slovakia
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Žilina
Slovakia
01207
Slovakia
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Bratislava
SK-81369
Slovakia
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Bern
3010
Switzerland
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Lausanne
1011
Switzerland
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Zurich
8091
Switzerland
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London
England
E11 1NR
United Kingdom
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Birmingham
B15 2TH
United Kingdom
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Blackpool
FY3 7EN
United Kingdom
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Leicester
LE7 5WW
United Kingdom
Novartis Investigative Site
Poole
BH15 2JB
United Kingdom
Novartis Investigative Site
Hanoi
Vietnam
1000
Vietnam
Novartis Investigative Site
Hanoi
1000
Vietnam
Novartis Investigative Site
Ho Chi Minh City
7000
Vietnam
Derived
Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.
The Full analysis set (FAS) was comprised of all patients to whom study treatment had been assigned.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
BG001
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000482
BG001484
BG002966
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00045.3± 12.83
BG00146.7± 12.83
BG00246.0± 12.84
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000177
BG001151
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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)
Full analysis set (FAS) - All patients to whom study treatment was assigned.
Posted
Number
Percent of participants
Week 40 , week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline, week 2, 3 , 4, 8, 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
PASI: Combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
OG002
AIN457 150 mg - Fixed Interval (FI)
Secondary
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percent of participant
Baseline, week 2, 4, 6, 8, 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
AIN457 300 mg - IPO
Secondary
Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percent of participants
Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline to week 2, 4, 8, 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline to week 2, 4, 8, 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Mean
Standard Deviation
Units on a scale
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percent of participants
Baseline to week 2, 4, 6, 8, 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percent of participant
Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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). A negative mean percentage change indicates improvement
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Median
95% Confidence Interval
Number of weeks
Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
OG002
AIN457 150 mg - Fixed Interval (FI)
Secondary
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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.
Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
Posted
Number
Percent of participants
Week 12
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
Secondary
Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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.
Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included
Posted
Number
Percent of participants
Week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
Secondary
Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
PASI is a combined assessment of lesion severity and 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 and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and 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 and 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.
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Percent of participants
Week 16, 20, 24,28,32,36,40,44,48,and Week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
OG001
AIN457 300 mg - IPO
Secondary
Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
percent of participants
week 16, 20, 24,28,32,36,40,44,48,and Week 52
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Number of Participants Developing Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60
Full analysis set (FAS) - All patients to whom study treatment was assigned
Posted
Number
Number of participants
Baseline, weeks 12, 24, 52 and 60
ID
Title
Description
OG000
AIN457150 mg- Induction Period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
BENIGN BREAST NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
PITUITARY TUMOUR BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
CENTRAL NERVOUS SYSTEM INFLAMMATION
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
HAEMORRHAGIC STROKE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
MULTIPLE SCLEROSIS
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
VASCULAR HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
ALCOHOL ABUSE
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
ALCOHOL WITHDRAWAL SYNDROME
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
ALCOHOLISM
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
CALCULUS URETERIC
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
IGA NEPHROPATHY
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
RENAL TUBULAR NECROSIS
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
METRORRHAGIA
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
VARICOCELE
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
VULVA CYST
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PLEURISY
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
SLEEP APNOEA SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
DERMAL CYST
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PEMPHIGUS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
PHOTOSENSITIVITY REACTION
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PUSTULAR PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
FEMORAL ARTERY OCCLUSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
GRANULOMATOSIS WITH POLYANGIITIS
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PERIPHERAL ARTERY STENOSIS
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG0030 affected217 at risk
EG0040 affected205 at risk
EG0050 affected217 at risk
EG0060 affected27 at risk
EG0070 affected23 at risk
EG0080 affected40 at risk
EG0090 affected39 at risk
EG0101 affected39 at risk
EG0110 affected35 at risk
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
CATARACT
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0013 affected484 at risk
EG0023 affected203 at risk
EG003
ABDOMINAL TENDERNESS
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0012 affected484 at risk
EG0020 affected203 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0007 affected482 at risk
EG0018 affected484 at risk
EG0026 affected203 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0014 affected484 at risk
EG0025 affected203 at risk
EG003
HYPERCHLORHYDRIA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected482 at risk
EG0014 affected484 at risk
EG0025 affected203 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0010 affected484 at risk
EG0024 affected203 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0013 affected484 at risk
EG0022 affected203 at risk
EG003
ASTHENIA
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0013 affected484 at risk
EG0021 affected203 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0014 affected484 at risk
EG0020 affected203 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected482 at risk
EG0014 affected484 at risk
EG0024 affected203 at risk
EG003
PYREXIA
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0010 affected484 at risk
EG0024 affected203 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0016 affected484 at risk
EG00211 affected203 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0013 affected484 at risk
EG0022 affected203 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0012 affected484 at risk
EG0027 affected203 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0011 affected484 at risk
EG0023 affected203 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0006 affected482 at risk
EG0016 affected484 at risk
EG0029 affected203 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00048 affected482 at risk
EG00146 affected484 at risk
EG00237 affected203 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0012 affected484 at risk
EG0022 affected203 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected482 at risk
EG0019 affected484 at risk
EG0028 affected203 at risk
EG003
PHARYNGITIS BACTERIAL
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0013 affected484 at risk
EG0024 affected203 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0013 affected484 at risk
EG0023 affected203 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00017 affected482 at risk
EG00117 affected484 at risk
EG00216 affected203 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0013 affected484 at risk
EG0023 affected203 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0012 affected484 at risk
EG0021 affected203 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 16.0
Systematic Assessment
EG0004 affected482 at risk
EG0013 affected484 at risk
EG0024 affected203 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0010 affected484 at risk
EG0023 affected203 at risk
EG003
DYSLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0012 affected484 at risk
EG0022 affected203 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0005 affected482 at risk
EG0015 affected484 at risk
EG0023 affected203 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0022 affected203 at risk
EG003
HYPERLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0012 affected484 at risk
EG0022 affected203 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0010 affected484 at risk
EG0022 affected203 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0009 affected482 at risk
EG0019 affected484 at risk
EG0028 affected203 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected482 at risk
EG0014 affected484 at risk
EG00212 affected203 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0011 affected484 at risk
EG0023 affected203 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0006 affected482 at risk
EG0012 affected484 at risk
EG0025 affected203 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected482 at risk
EG0011 affected484 at risk
EG0025 affected203 at risk
EG003
SPINAL OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
SEBORRHOEIC KERATOSIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00022 affected482 at risk
EG00117 affected484 at risk
EG00214 affected203 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0011 affected484 at risk
EG0022 affected203 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0009 affected482 at risk
EG0011 affected484 at risk
EG0026 affected203 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0021 affected203 at risk
EG003
GLYCOSURIA
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
KETONURIA
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected482 at risk
EG00110 affected484 at risk
EG00213 affected203 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0017 affected484 at risk
EG0023 affected203 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 affected482 at risk
EG0013 affected484 at risk
EG0025 affected203 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0013 affected484 at risk
EG0020 affected203 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected482 at risk
EG0011 affected484 at risk
EG0023 affected203 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0016 affected484 at risk
EG0020 affected203 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0012 affected484 at risk
EG0021 affected203 at risk
EG003
ERYTHRODERMIC PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG00020 affected482 at risk
EG00112 affected484 at risk
EG00212 affected203 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected482 at risk
EG0017 affected484 at risk
EG0020 affected203 at risk
EG003
PUSTULAR PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0011 affected484 at risk
EG0020 affected203 at risk
EG003
SEBORRHOEIC DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected482 at risk
EG0012 affected484 at risk
EG0025 affected203 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected482 at risk
EG0010 affected484 at risk
EG0020 affected203 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected482 at risk
EG0014 affected484 at risk
EG0026 affected203 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG00011 affected482 at risk
EG00111 affected484 at risk
EG0029 affected203 at risk
EG003
A limitation of this study is the lack of a placebo group; however, because the placebo response is very low in psoriasis, it is inappropriate to maintain patients on placebo for 52 weeks. .
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety