Clinical Trial Results:
Secukinumab In patients with moderate to severe active, chronic plaque psoriasis who have failed on tumor necrosis factor alpha (TNFα) antaGoNists: A clinical Trial EvalUating Treatment REsults
Summary
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EudraCT number |
2013-001855-11 |
Trial protocol |
GB IE |
Global end of trial date |
12 Jul 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Feb 2018
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First version publication date |
02 Feb 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CAIN457AGB01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01961609 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH-4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 4163241111,
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 4163241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Jul 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jul 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to evaluate the efficacy of secukinumab (300mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0).
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Oct 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Ireland: 12
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Country: Number of subjects enrolled |
United Kingdom: 223
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Worldwide total number of subjects |
235
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EEA total number of subjects |
235
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
223
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks. | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Initiation (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Secukinumab (AIN457) 300 mg | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Secukinumab
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Investigational medicinal product code |
AIN457
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants self-administered 300 mg
secukinumab loading dose subcutaneously at
Day 0 (initiation of study drug) and at weeks
1, 2, 3 & 4, and then every 4 weeks.
Following the Primary Endpoint at 16 weeks,
participants meeting the National Institute
for Health and Care Excellence (NICE) criteria
of adequate response were eligible to
continue on study treatment for a further 32
weeks. Participants not meeting this NICE
criterion returned to routine treatment under
the care of their usual Clinical Team.
Following assessment at week 48,
participants meeting the NICE criteria of
adequate response were eligible to continue
on study treatment for a further 24 weeks.
Participants not meeting this NICE criterion
returned to routine treatment under the care
of their usual Clinical Team.
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Arm title
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Secukinumab (AIN457) 150 mg | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Secukinumab
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Investigational medicinal product code |
AIN457
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants self-administered secukinumab
150 mg loading dose subcutaneously at Day
0 (initiation of study drug), weeks 1, 2, 3 & 4
and then every 4 weeks. Following the
Primary Endpoint at 16 weeks, participants
meeting the NICE criteria of adequate
response were eligible to continue on study
treatment for a further 32 weeks at the
150mg dose. Participants not achieving the
NICE criteria at the Primary Endpoint were
up titrated to 300mg at the discretion of the
treating physician. Following assessment at
week 48, participants meeting the NICE
criteria of adequate response were eligible to
continue on study treatment for a further 24
weeks at the 150mg dose. Participants not
achieving the NICE criteria at 48 weeks on
the 150mg dose were up titrated to 300mg
at the discretion of the treating physician.
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Baseline characteristics reporting groups
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Reporting group title |
Secukinumab (AIN457) 300 mg
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Reporting group description |
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Secukinumab (AIN457) 150 mg
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Reporting group description |
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Secukinumab (AIN457) 300 mg
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Reporting group description |
Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. | ||
Reporting group title |
Secukinumab (AIN457) 150 mg
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Reporting group description |
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. | ||
Subject analysis set title |
Secukinumab (AIN457) 300 mg subgroup 1
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
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Subject analysis set title |
Secukinumab (AIN457) 300 mg subgroup 2
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
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Subject analysis set title |
Secukinumab (AIN457) 300 mg subgroup 3
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All participants who have tried and failed more than one anti-TNFalpha therapies
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Subject analysis set title |
Secukinumab (AIN457) 150 mg subgroup 1
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy
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Subject analysis set title |
Secukinumab (AIN457) 150 mg subgroup 2
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response
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Subject analysis set title |
Secukinumab (AIN457) 150 mg subgroup 3
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All participants who have tried and failed more than one anti-TNFalpha therapies
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Subject analysis set title |
Secukinumab (AIN457A) 300 mg subgroups 1 and 2 combined
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.
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Subject analysis set title |
Secukinumab (AIN457) 150 mg subgroups 1 and 2 combined
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.
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Subject analysis set title |
Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.
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Subject analysis set title |
Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.
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End point title |
Percentage of secukinumab 300 mg participants achieving PASI 75 at 16 weeks [1] [2] | ||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Primary
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End point timeframe |
16 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis applies to the Secukinumab (AIN457) 300 mg group only. Non-inferiority/equivalence test = No P-Value: <0.0001 Method of estimation: 2-sided binomial exact test Estimated value: 65.3 percent (A Bonferroni adjustment adjusting for 8 analyses have been applied.) 99.375% Confidence interval, 2-sided: 52.4 to 76.7 [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: All arms do not apply to this end point. |
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No statistical analyses for this end point |
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End point title |
Percentage of secukinumab 150 mg participants achieving PASI 75 at 16 weeks [3] | ||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
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End point timeframe |
16 Weeks
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Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: All arms do not apply to this end point. |
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieving PASI 75 according to 3 key participant subgroups (Primary Inadequate Response (IR), Secondary IR and IR after more than one anti-TNFalpha therapies) at 16 weeks | ||||||||||||||||||||||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
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End point timeframe |
16 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieiving PASI 75 - Initiation Period | |||||||||||||||||||||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
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End point timeframe |
2 ,4, 8, 12 and 16 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieiving PASI 75 - Maintenance 1 Period | ||||||||||||||||||||||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
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End point timeframe |
16, 24 and 48 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieiving PASI 75 - Maintenance 2 Period | ||||||||||||||||||||||||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
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End point timeframe |
48 and 72 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieving PASI 50 and PASI 90 - Initiation Period | ||||||||||||||||||||||||||||||||||||||||||
End point description |
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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
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End point type |
Secondary
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End point timeframe |
2, 4, 8, 12, 16 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 1 Period | ||||||||||||||||||||||||||||||||||||||||
End point description |
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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
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End point type |
Secondary
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End point timeframe |
16, 24 and 48 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 2 Period | ||||||||||||||||||||||||||||||||||||||||
End point description |
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 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
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End point type |
Secondary
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End point timeframe |
48 and 72 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants who have failed on one anti-TNFα achieving PASI 75 (subgroups 1 and 2 combined) at 16 weeks | ||||||||||||
End point description |
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 75 is defined as participants achieving ≥ 75% improvement from baseline.
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End point type |
Secondary
|
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End point timeframe |
16 Weeks
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No statistical analyses for this end point |
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End point title |
Percentage of participants achieving NICE continuation criteria (PASI 75 or PASI 50 plus a 5 point improvement in DLQI) at 16 weeks | ||||||||||||
End point description |
PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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.
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End point type |
Secondary
|
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End point timeframe |
16 Weeks
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Initiation Period | ||||||||||||||||||
End point 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. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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. A negative change from baseline indicates improvement.
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End point type |
Secondary
|
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End point timeframe |
12 and 16 weeks
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 1 Period | ||||||||||||||||||||||||||||
End point 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. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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. A negative change from baseline indicates improvement.
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End point type |
Secondary
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End point timeframe |
16, 24 and 48 weeks
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 2 Period | ||||||||||||||||||||||||||||||
End point 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. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. 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. A negative change from baseline indicates improvement.
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End point type |
Secondary
|
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End point timeframe |
48 and 72 weeks
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No statistical analyses for this end point |
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End point title |
Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Initiation Period | ||||||||||||||||||
End point description |
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
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End point type |
Secondary
|
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End point timeframe |
12 and 16 weeks
|
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No statistical analyses for this end point |
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End point title |
Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 1 Period | ||||||||||||||||||||||||||||
End point description |
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
|
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End point type |
Secondary
|
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End point timeframe |
16, 24 and 48 weeks
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 2 Period | ||||||||||||||||||||||||||||||
End point description |
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
|
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End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
48 and 72 weeks
|
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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Adverse event reporting additional description |
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Secukinumab 150mg
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Reporting group description |
Secukinumab 150mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Secukinumab 300mg
|
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Reporting group description |
Secukinumab 300mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Aug 2013 |
The main purpose of this amendment was that female patients were required to use two effective forms of contraception and male patients were required to use one effective form of contraception |
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28 Nov 2013 |
The main purposes of this amendment were the primary endpoint was changed from 12 weeks to 16 weeks; 12 weeks efficacy was included as a secondary endpoint; the option of up titration at for patients on the 150mg dose secukinumab to 300mg if they were not achieving the NICE criteria; and administrative changes. |
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03 Jul 2014 |
The main purpose of this amendment was to further evaluate: secukinumab safety, efficacy and tolerability for a further 24 weeks; patient response in those patients not achieving adequate efficacy on 150mg secukinumab at Week 48, when up-titrated to 300mg; PASI 50, 75 and 90 response at 24, 48 and 72 weeks; and previous exposure to Ustekinumab no longer an exclusion criteria. |
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22 Feb 2016 |
Minor administrative updates were made to the protocol including: an updated author and steering committee list; minor corrections to the numbering of days for maintenance period 2; Updates to the patient exposure and post-marketing experience information; Update to the use of the results and interim analysis; Clarification on the acceptable duration of concomitant mild-moderate topical steroids; Clarification on prohibited meds; Correction to the description of the statistical model, hypothesis and method of analysis section |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |