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    Clinical Trial Results:
    A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-α agents

    Summary
    EudraCT number
    		 2011-006058-94
    Trial protocol
    		 CZ   DE   IT   PT   GR  
    Global end of trial date
    11 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2016
    First version publication date
    20 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2311
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01770379
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active Rheumatoid Arthritis (RA) based on the proportion of patients achieving an American College of Rheumatology (ACR)20 response.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Brazil: 11
    Country: Number of subjects enrolled
    Czech Republic: 16
    Country: Number of subjects enrolled
    Dominican Republic: 3
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Guatemala: 6
    Country: Number of subjects enrolled
    India: 20
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Japan: 28
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Panama: 7
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    Greece: 9
    Worldwide total number of subjects
    242
    EEA total number of subjects
    65
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    201
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 RA classified by ACR 2010 revised criteria for at least 3 months before screening and at baseline, Disease activity criteria defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 75 mg
    Arm description
    		 Patients received AIN457 75 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of week 16 responder status.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    75 mg in 0.5ml PFS for injection

    Arm title
    		 AIN457 150mg
    Arm description
    		 Patients received AIN457 150 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of week 16 responder status.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1.0ml PFS for injection

    Arm title
    		 Placebo
    Arm description
    		 Patients received placebo as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non-responders were re-randomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24; these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo in 0.5 or 1.0ml PFS for injection (Double Dummy Design)

    Number of subjects in period 1
    		AIN457 75 mg AIN457 150mg Placebo
    Started
    80
    81
    81
    Completed
    41
    37
    39
    Not completed
    39
    44
    42
         Consent withdrawn by subject
    7
    10
    7
         Physician decision
    -
    1
    2
         Adverse event, non-fatal
    1
    3
    2
         study terminated by sponsor
    22
    23
    22
         Lost to follow-up
    -
    -
    2
         Technical issues
    1
    -
    -
         Lack of efficacy
    8
    6
    6
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 75 mg
    Reporting group description
    		 Patients received AIN457 75 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of week 16 responder status.

    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Patients received AIN457 150 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of week 16 responder status.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received placebo as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non-responders were re-randomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24; these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1).

    Reporting group values
    		 AIN457 75 mg AIN457 150mg Placebo Total
    Number of subjects
    		 80 81 81 242
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 70 62 69 201
        >=65 years
    		 10 19 12 41
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 53.2 ( 10.2 ) 55.1 ( 12.7 ) 54.2 ( 11 ) -
    Gender, Male/Female
    Units: participant
        Female
    		 70 67 65 202
        Male
    		 10 14 16 40

    End points

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    End points reporting groups
    Reporting group title
    AIN457 75 mg
    Reporting group description
    		 Patients received AIN457 75 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of week 16 responder status.

    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Patients received AIN457 150 mg as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of week 16 responder status.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received placebo as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4. At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non-responders were re-randomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24; these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1).

    Primary: Percentage of participants achieving an American College of Rheumatology Response 20 (ACR20).

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    End point title
    		 Percentage of participants achieving an American College of Rheumatology Response 20 (ACR20).
    End point description
    ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 AIN457 75 mg AIN457 150mg Placebo
    Number of subjects analysed
    80
    81
    81
    Units: percentage of participants
        number (not applicable)
    37.5
    38.3
    27.2
    Statistical analysis title
    		 AIN457A 75mg vs. Placebo
    Comparison groups
    AIN457 75 mg v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 3.03
    Statistical analysis title
    		 AIN457A 150 mg vs. placebo
    Comparison groups
    AIN457 150mg v Placebo
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1574
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 3.15

    Secondary: Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP)

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    End point title
    		 Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP)
    End point description
    The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 AIN457 75 mg AIN457 150mg Placebo
    Number of subjects analysed
    80
    81
    81
    Units: Units on a scale
        least squares mean (standard error)
    -1.56 ( 0.149 )
    -1.61 ( 0.148 )
    -1.01 ( 0.176 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

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    End point title
    		 Change from baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
    End point description
    The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 AIN457 75 mg AIN457 150mg Placebo
    Number of subjects analysed
    80
    81
    81
    Units: units on a scale
        least squares mean (standard error)
    -0.42 ( 0.068 )
    -0.39 ( 0.068 )
    -0.13 ( 0.078 )
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving ACR50

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    End point title
    		 Percentage of participants achieving ACR50
    End point description
    ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 AIN457 75 mg AIN457 150mg Placebo
    Number of subjects analysed
    80
    81
    81
    Units: Percentage of patients
        number (not applicable)
    17.5
    18.5
    13.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Any AIN457 75 mg
    Reporting group description
    		 Any AIN457 75 mg

    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Any AIN457 150 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Any AIN457 75 mg Any AIN457 150 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 115 (10.43%)
    9 / 115 (7.83%)
    0 / 79 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Synovial rupture
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dementia
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 115 (1.74%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Any AIN457 75 mg Any AIN457 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 115 (66.96%)
    63 / 115 (54.78%)
    35 / 79 (44.30%)
    Investigations
    Weight increased
         subjects affected / exposed
    2 / 115 (1.74%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    2
    3
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 115 (0.87%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    1
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 115 (4.35%)
    6 / 115 (5.22%)
    0 / 79 (0.00%)
         occurrences all number
    5
    7
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 115 (2.61%)
    4 / 115 (3.48%)
    1 / 79 (1.27%)
         occurrences all number
    6
    4
    1
    Headache
         subjects affected / exposed
    6 / 115 (5.22%)
    10 / 115 (8.70%)
    2 / 79 (2.53%)
         occurrences all number
    8
    11
    3
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    5 / 115 (4.35%)
    1 / 115 (0.87%)
    1 / 79 (1.27%)
         occurrences all number
    9
    4
    6
    Oedema peripheral
         subjects affected / exposed
    1 / 115 (0.87%)
    4 / 115 (3.48%)
    2 / 79 (2.53%)
         occurrences all number
    1
    4
    2
    Pyrexia
         subjects affected / exposed
    5 / 115 (4.35%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences all number
    5
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 115 (0.87%)
    3 / 115 (2.61%)
    1 / 79 (1.27%)
         occurrences all number
    1
    3
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 115 (1.74%)
    3 / 115 (2.61%)
    1 / 79 (1.27%)
         occurrences all number
    2
    4
    1
    Dental caries
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences all number
    3
    0
    0
    Diarrhoea
         subjects affected / exposed
    8 / 115 (6.96%)
    9 / 115 (7.83%)
    1 / 79 (1.27%)
         occurrences all number
    12
    9
    1
    Dyspepsia
         subjects affected / exposed
    7 / 115 (6.09%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    7
    3
    0
    Nausea
         subjects affected / exposed
    4 / 115 (3.48%)
    6 / 115 (5.22%)
    1 / 79 (1.27%)
         occurrences all number
    4
    6
    1
    Stomatitis
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 115 (0.00%)
    1 / 79 (1.27%)
         occurrences all number
    4
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 115 (1.74%)
    6 / 115 (5.22%)
    1 / 79 (1.27%)
         occurrences all number
    2
    6
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 115 (10.43%)
    2 / 115 (1.74%)
    0 / 79 (0.00%)
         occurrences all number
    14
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 115 (0.87%)
    2 / 79 (2.53%)
         occurrences all number
    1
    1
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 115 (0.87%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    1
    3
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 115 (0.00%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    2
    Rash
         subjects affected / exposed
    5 / 115 (4.35%)
    4 / 115 (3.48%)
    1 / 79 (1.27%)
         occurrences all number
    5
    5
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 115 (2.61%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences all number
    3
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 115 (4.35%)
    2 / 115 (1.74%)
    3 / 79 (3.80%)
         occurrences all number
    6
    4
    3
    Back pain
         subjects affected / exposed
    4 / 115 (3.48%)
    4 / 115 (3.48%)
    0 / 79 (0.00%)
         occurrences all number
    4
    4
    0
    Musculoskeletal pain
         subjects affected / exposed
    5 / 115 (4.35%)
    1 / 115 (0.87%)
    0 / 79 (0.00%)
         occurrences all number
    5
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 115 (3.48%)
    0 / 79 (0.00%)
         occurrences all number
    0
    4
    0
    Pain in extremity
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
    2 / 79 (2.53%)
         occurrences all number
    0
    2
    2
    Rheumatoid arthritis
         subjects affected / exposed
    11 / 115 (9.57%)
    10 / 115 (8.70%)
    6 / 79 (7.59%)
         occurrences all number
    13
    14
    7
    Rheumatoid nodule
         subjects affected / exposed
    0 / 115 (0.00%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    0
    3
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    14 / 115 (12.17%)
    4 / 115 (3.48%)
    4 / 79 (5.06%)
         occurrences all number
    20
    5
    4
    Cystitis
         subjects affected / exposed
    4 / 115 (3.48%)
    3 / 115 (2.61%)
    1 / 79 (1.27%)
         occurrences all number
    7
    3
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 115 (0.00%)
    3 / 115 (2.61%)
    0 / 79 (0.00%)
         occurrences all number
    0
    3
    0
    Influenza
         subjects affected / exposed
    5 / 115 (4.35%)
    2 / 115 (1.74%)
    0 / 79 (0.00%)
         occurrences all number
    5
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 115 (0.00%)
    0 / 79 (0.00%)
         occurrences all number
    4
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 115 (0.00%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    25 / 115 (21.74%)
    23 / 115 (20.00%)
    8 / 79 (10.13%)
         occurrences all number
    41
    41
    8
    Rhinitis
         subjects affected / exposed
    5 / 115 (4.35%)
    5 / 115 (4.35%)
    1 / 79 (1.27%)
         occurrences all number
    5
    6
    1
    Sinusitis
         subjects affected / exposed
    2 / 115 (1.74%)
    2 / 115 (1.74%)
    2 / 79 (2.53%)
         occurrences all number
    2
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 115 (6.96%)
    9 / 115 (7.83%)
    3 / 79 (3.80%)
         occurrences all number
    9
    10
    4
    Urinary tract infection
         subjects affected / exposed
    9 / 115 (7.83%)
    2 / 115 (1.74%)
    2 / 79 (2.53%)
         occurrences all number
    10
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2012
    • To align the sequence of the hierarchical testing strategy with latest FDA guidance released May 2013 for clinical trials in patients with RA. • To fulfill health authority requests with regards to local requirements for additional serological testing (hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)) prior to initiation of therapy. • To fulfill a health authority request, to limit blinded study duration to reduce patient burden in administering a second syringe containing placebo to maintain blind At the time of this amendment, approximately half of the patients had been randomized. This amendment was not considered to have affected the interpretation of study results as the changes were minor and occurred prior to study unblinding.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated early (unrelated to safety) due to the analysis of AIN457F2309 study ,which the data showed that secukinumab is not comparable to current RA treatments thus closing the AIN457 RA program.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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