Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44043   clinical trials with a EudraCT protocol, of which   7319   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis

    Summary
    EudraCT number
    		 2013-001089-40
    Trial protocol
    		 IT   GB   DE   NL   BG   BE  
    Global end of trial date
    16 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2019
    First version publication date
    29 Mar 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2305E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01863732
    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, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    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
    16 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the sustainability of subject benefits as quantified by the ASAS20 (Assessment of SpondyloArthritis International Society criteria) in the whole study population during long term (Week 260) treatment with secukinumab 75 and 150 mg provided as prefilled syringes
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Peru: 29
    Country: Number of subjects enrolled
    Russian Federation: 57
    Country: Number of subjects enrolled
    Taiwan: 48
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    274
    EEA total number of subjects
    96
    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)
    261
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 CAIN457F2305 core study consisted of a screening period of 4 Wks before randomization followed by a treatment period of 2 years (Wk 0 through Wk 104). At Wk 104, patients continued into the extension on the same dose of AIN457. If they were on Placebo in the core then randomized to either Group 1 or 2.

    Pre-assignment
    Screening details
    		 Group 1: AIN457 75mg plus placebo 150mg dosed every 4 weeks from Wk 104E1 to Wk 152. At Wk 156 (after unblinding), only AIN457 75mg was dosed or up titrated to AIN457 150mg. Group 2: AIN457 150mg plus placebo 75mg dosed every 4 weeks from Wk 104E1 through Wk 152. At Wk 156 (after unblinding), only secukinumab 150 mg was dosed.

    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, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab (AIN457) 75mg Grp1
    Arm description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
    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
    Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 260

    Investigational medicinal product name
    Placebo
    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
    Placebo to match Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    Arm title
    		 Secukinumab (AIN457) 75 to 150mg Grp1
    Arm description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
    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
    Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 156 then up titrated to 150mg

    Investigational medicinal product name
    Placebo
    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
    Placebo to match Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    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
    Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks from week 156 until week 260

    Arm title
    		 Secukinumab (AIN457) 150mg Grp2
    Arm description
    		 Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
    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
    Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 260

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use, Subcutaneous use
    Dosage and administration details
    Placebo to match Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    Arm title
    		 Pbo in Core then AIN457 75mg Grp1
    Arm description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W
    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
    Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 260

    Investigational medicinal product name
    Placebo
    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
    Placebo to match Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    Arm title
    		 Pbo in Core then AIN457 75 to 150mg Grp1
    Arm description
    		 Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W
    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
    Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 156 then up titrated to 150mg

    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
    Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks from week 156 until week 260

    Investigational medicinal product name
    Placebo
    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
    Placebo to match Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    Arm title
    		 Pbo in Core then AIN457 150mg Grp2
    Arm description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    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
    Placebo to match Secukinumab 75 mg in 0.5 mL in prefilled syringes subcutaneously every 4 weeks for until week 156

    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
    Secukinumab 150 mg in 1 mL in prefilled syringes subcutaneously every 4 weeks for until week 260

    Number of subjects in period 1
    		Secukinumab (AIN457) 75mg Grp1 Secukinumab (AIN457) 75 to 150mg Grp1 Secukinumab (AIN457) 150mg Grp2 Pbo in Core then AIN457 75mg Grp1 Pbo in Core then AIN457 75 to 150mg Grp1 Pbo in Core then AIN457 150mg Grp2
    Started
    41
    59
    87
    23
    23
    41
    Completed
    30
    57
    75
    15
    20
    33
    Not completed
    11
    2
    12
    8
    3
    8
         Adverse event, serious fatal
    1
    -
    -
    -
    -
    1
         Physician decision
    1
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    -
    3
    -
    3
         Technical problems
    -
    -
    1
    1
    -
    -
         Pregnancy
    -
    -
    -
    -
    -
    1
         Lost to follow-up
    1
    1
    2
    1
    -
    1
         Subject/guardian decision
    6
    -
    9
    2
    1
    1
         Lack of efficacy
    1
    -
    -
    1
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab (AIN457) 75mg Grp1
    Reporting group description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Secukinumab (AIN457) 75 to 150mg Grp1
    Reporting group description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Secukinumab (AIN457) 150mg Grp2
    Reporting group description
    		 Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 75mg Grp1
    Reporting group description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 75 to 150mg Grp1
    Reporting group description
    		 Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 150mg Grp2
    Reporting group description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group values
    		 Secukinumab (AIN457) 75mg Grp1 Secukinumab (AIN457) 75 to 150mg Grp1 Secukinumab (AIN457) 150mg Grp2 Pbo in Core then AIN457 75mg Grp1 Pbo in Core then AIN457 75 to 150mg Grp1 Pbo in Core then AIN457 150mg Grp2 Total
    Number of subjects
    		 41 59 87 23 23 41 274
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 38 56 86 21 21 39 261
        From 65-84 years
    		 3 3 1 2 2 2 13
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.5 ( 13.37 ) 40.9 ( 13.36 ) 38.2 ( 11.58 ) 43.0 ( 13.00 ) 40.0 ( 12.43 ) 42.5 ( 12.13 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 12 13 29 7 3 12 76
        Male
    		 29 46 58 16 20 29 198
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 3 7 1 0 1 12
        Asian
    		 6 13 15 3 5 8 50
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0 0
        White
    		 25 36 48 13 17 28 167
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 10 7 17 6 1 4 45

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Secukinumab (AIN457) 75mg Grp1
    Reporting group description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Secukinumab (AIN457) 75 to 150mg Grp1
    Reporting group description
    		 Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Secukinumab (AIN457) 150mg Grp2
    Reporting group description
    		 Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 75mg Grp1
    Reporting group description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 75 to 150mg Grp1
    Reporting group description
    		 Participants were on Placebo in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W

    Reporting group title
    Pbo in Core then AIN457 150mg Grp2
    Reporting group description
    		 Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W

    Primary: Assessment of Spondyloarthritis International Society criteria (ASAS) 20 response from Week 104 to Week 260

    		 Close Top of page
    End point title
    		 Assessment of Spondyloarthritis International Society criteria (ASAS) 20 response from Week 104 to Week 260 [1]
    End point description
    ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed
    End point type
    Primary
    End point timeframe
    Week 104 to Week 260
    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: No statistical analysis was planned for this primary outcome
    End point values
    		 Secukinumab (AIN457) 75mg Grp1 Secukinumab (AIN457) 75 to 150mg Grp1 Secukinumab (AIN457) 150mg Grp2 Pbo in Core then AIN457 75mg Grp1 Pbo in Core then AIN457 75 to 150mg Grp1 Pbo in Core then AIN457 150mg Grp2
    Number of subjects analysed
    41
    59
    87
    23
    23
    41
    Units: % of responders
    number (not applicable)
        Week 104 (n=84,n=0, n=80,n=42,n=0, n=37)
    71.4
    0
    80.0
    78.6
    0
    73.0
        Week 116 (n=96,n=0, n=84,n=46,n=0, n=41)
    76.0
    0
    82.1
    76.1
    0
    70.7
        Week 128 (n=97,n=0, n=83,n=46,n=0, n=40)
    70.1
    0
    77.1
    84.8
    0
    75.0
        Week 140 (n=96,n=0, n=84,n=45,n=0, n=40)
    77.1
    0
    75.0
    75.6
    0
    72.5
        Week 156 (n=98,n=0, n=86,n=46,n=0, n=40)
    75.5
    0
    80.2
    76.1
    0
    78.4
        Week 168 (n=95,n=0, n=83,n=42,n=0, n=37)
    74.7
    0
    78.3
    83.3
    0
    78.4
        Week 180 (n=92,n=1, n=80,n=41,n=1, n=37)
    81.5
    100.0
    80.0
    82.9
    0
    78.4
        Week 192 (n=82,n=12, n=79,n=36,n=6, n=37)
    69.5
    91.7
    84.8
    83.3
    66.7
    73.0
        Week 208 (n=69,n=25, n=79,n=28,n=12, n=37)
    71.0
    80.0
    79.7
    78.6
    66.7
    78.4
        Week 220 (n=51,n=39, n=77,n=23,n=14, n=36)
    68.6
    82.1
    81.8
    91.3
    64.3
    75.0
        Week 232 (n=39,n=51, n=78,n=20,n=17, n=36)
    82.1
    72.5
    82.1
    80.0
    70.6
    77.8
        Week 244 (n=30,n=57, n=78,n=15,n=20, n=34)
    76.7
    73.7
    82.1
    80.0
    80.0
    76.5
        Week 260 (n=31,n=56, n=76,n=16,n=22, n=36)
    67.7
    73.2
    77.6
    81.3
    81.8
    80.6
    No statistical analyses for this end point

    Secondary: Assessment of Spondyloarthritis International Society criteria (ASAS) 40 response from Week 104 to Week 260

    		 Close Top of page
    End point title
    		 Assessment of Spondyloarthritis International Society criteria (ASAS) 40 response from Week 104 to Week 260
    End point description
    ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed
    End point type
    Secondary
    End point timeframe
    Week 104 to Week 260
    End point values
    		 Secukinumab (AIN457) 75mg Grp1 Secukinumab (AIN457) 75 to 150mg Grp1 Secukinumab (AIN457) 150mg Grp2 Pbo in Core then AIN457 75mg Grp1 Pbo in Core then AIN457 75 to 150mg Grp1 Pbo in Core then AIN457 150mg Grp2
    Number of subjects analysed
    41
    59
    87
    23
    23
    41
    Units: % of responders
    number (not applicable)
        Week 104 (n=84,n=0, n=80,n=42,n=0, n=37)
    53.6
    0
    65.0
    57.1
    0
    48.6
        Week 116 (n=96,n=0, n=84,n=46,n=0, n=41)
    56.3
    0
    59.5
    54.3
    0
    51.2
        Week 128 (n=97,n=0, n=83,n=46,n=0, n=40)
    54.6
    0
    68.7
    58.7
    0
    55.0
        Week 140 (n=96,n=0, n=84,n=45,n=0, n=40)
    53.1
    0
    60.7
    53.3
    0
    60.0
        Week 156 (n=98,n=0, n=86,n=46,n=0, n=40)
    50.0
    0
    62.8
    54.3
    0
    55.0
        Week 168 (n=95,n=0, n=83,n=42,n=0, n=37)
    54.7
    0
    67.5
    42.9
    0
    62.2
        Week 180 (n=92,n=1, n=80,n=41,n=1, n=37)
    53.3
    0
    68.8
    53.7
    0.0
    67.6
        Week 192 (n=82,n=12, n=79,n=36,n=6, n=37)
    53.7
    83.3
    69.6
    52.8
    50.0
    62.2
        Week 208 (n=69,n=25, n=79,n=28,n=12, n=37)
    43.5
    76.0
    60.8
    64.3
    58.3
    56.8
        Week 220 (n=51,n=39, n=77,n=23,n=14, n=36)
    45.1
    59.0
    67.5
    56.5
    50.0
    63.9
        Week 232 (n=39,n=51, n=78,n=20,n=17, n=36)
    59.0
    64.7
    66.7
    60.0
    58.8
    69.4
        Week 244 (n=30,n=57, n=78,n=15,n=20, n=34)
    60.0
    61.4
    70.5
    60.0
    65.0
    61.8
        Week 260 (n=31,n=56, n=76,n=16,n=22, n=36)
    54.8
    48.2
    64.5
    56.3
    68.2
    66.7
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    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
    36 / 179 (20.11%)
    33 / 263 (12.55%)
    5 / 122 (4.10%)
         number of deaths (all causes)
    2
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Breast cancer
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Lymphoma
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thymoma
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Vascular disorders
    Peripheral venous disease
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Varicose vein
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion incomplete
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Application site pain
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Chest discomfort
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Acute respiratory failure
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Dyspnoea
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Laryngeal oedema
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Nasal septum deviation
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Depression
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Product issues
    Device failure
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Craniocerebral injury
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Dislocation of vertebra
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Joint dislocation
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Laceration
         subjects affected / exposed
    2 / 179 (1.12%)
    0 / 263 (0.00%)
    0 / 122 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Postoperative thrombosis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Rib fracture
         subjects affected / exposed
    0 / 179 (0.00%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Tibia fracture
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Upper limb fracture
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Acute coronary syndrome
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Acute myocardial infarction
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Atrial fibrillation
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Atrial tachycardia
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Cardiac failure
         subjects affected / exposed
    1 / 179 (0.56%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Mitral valve incompetence
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Myocardial infarction
         subjects affected / exposed
    3 / 179 (1.68%)
    3 / 263 (1.14%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 179 (0.56%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Headache
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Hemiparesis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Ischaemic stroke
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Migraine
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Stroke in evolution
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Vocal cord paresis
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Anaemia
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Vertigo
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 263 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 179 (0.00%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 179 (0.00%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Crohn's disease
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Diarrhoea
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epigastric discomfort
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Gastritis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Hiatus hernia
         subjects affected / exposed
    2 / 179 (1.12%)
    0 / 263 (0.00%)
    0 / 122 (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
    Intestinal obstruction
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Lumbar hernia
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Cholangitis acute
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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 acute
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Cholelithiasis
         subjects affected / exposed
    3 / 179 (1.68%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Hepatosplenomegaly
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Urticaria
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Ureterolithiasis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    2 / 179 (1.12%)
    3 / 263 (1.14%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Back pain
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Bursitis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    0 / 179 (0.00%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Spinal column stenosis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Spondylolisthesis
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 263 (0.38%)
    0 / 122 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 179 (1.12%)
    0 / 263 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Cellulitis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Chronic sinusitis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Helicobacter gastritis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Pneumonia
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary tuberculoma
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Pyelonephritis acute
         subjects affected / exposed
    1 / 179 (0.56%)
    1 / 263 (0.38%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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
    Tonsillitis
         subjects affected / exposed
    0 / 179 (0.00%)
    2 / 263 (0.76%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 263 (0.00%)
    0 / 122 (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: 5%
    Non-serious adverse events
    		 Any AIN457 75 mg Any AIN457 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    126 / 179 (70.39%)
    157 / 263 (59.70%)
    45 / 122 (36.89%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 179 (7.26%)
    11 / 263 (4.18%)
    1 / 122 (0.82%)
         occurrences all number
    15
    12
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 179 (14.53%)
    28 / 263 (10.65%)
    7 / 122 (5.74%)
         occurrences all number
    35
    55
    12
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    14 / 179 (7.82%)
    11 / 263 (4.18%)
    1 / 122 (0.82%)
         occurrences all number
    19
    13
    1
    Eye disorders
    Uveitis
         subjects affected / exposed
    10 / 179 (5.59%)
    15 / 263 (5.70%)
    2 / 122 (1.64%)
         occurrences all number
    13
    25
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    9 / 179 (5.03%)
    9 / 263 (3.42%)
    0 / 122 (0.00%)
         occurrences all number
    11
    10
    0
    Diarrhoea
         subjects affected / exposed
    26 / 179 (14.53%)
    29 / 263 (11.03%)
    7 / 122 (5.74%)
         occurrences all number
    37
    47
    7
    Mouth ulceration
         subjects affected / exposed
    10 / 179 (5.59%)
    8 / 263 (3.04%)
    3 / 122 (2.46%)
         occurrences all number
    19
    16
    4
    Nausea
         subjects affected / exposed
    12 / 179 (6.70%)
    12 / 263 (4.56%)
    2 / 122 (1.64%)
         occurrences all number
    15
    15
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 179 (6.70%)
    18 / 263 (6.84%)
    2 / 122 (1.64%)
         occurrences all number
    14
    27
    2
    Oropharyngeal pain
         subjects affected / exposed
    14 / 179 (7.82%)
    18 / 263 (6.84%)
    6 / 122 (4.92%)
         occurrences all number
    27
    27
    6
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    11 / 179 (6.15%)
    13 / 263 (4.94%)
    4 / 122 (3.28%)
         occurrences all number
    13
    17
    5
    Arthralgia
         subjects affected / exposed
    17 / 179 (9.50%)
    24 / 263 (9.13%)
    4 / 122 (3.28%)
         occurrences all number
    30
    33
    5
    Back pain
         subjects affected / exposed
    13 / 179 (7.26%)
    20 / 263 (7.60%)
    0 / 122 (0.00%)
         occurrences all number
    15
    32
    0
    Neck pain
         subjects affected / exposed
    9 / 179 (5.03%)
    5 / 263 (1.90%)
    0 / 122 (0.00%)
         occurrences all number
    10
    8
    0
    Pain in extremity
         subjects affected / exposed
    9 / 179 (5.03%)
    7 / 263 (2.66%)
    2 / 122 (1.64%)
         occurrences all number
    16
    8
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    9 / 179 (5.03%)
    17 / 263 (6.46%)
    2 / 122 (1.64%)
         occurrences all number
    11
    17
    2
    Gastroenteritis
         subjects affected / exposed
    10 / 179 (5.59%)
    10 / 263 (3.80%)
    1 / 122 (0.82%)
         occurrences all number
    13
    13
    1
    Influenza
         subjects affected / exposed
    19 / 179 (10.61%)
    26 / 263 (9.89%)
    2 / 122 (1.64%)
         occurrences all number
    29
    39
    2
    Nasopharyngitis
         subjects affected / exposed
    45 / 179 (25.14%)
    63 / 263 (23.95%)
    9 / 122 (7.38%)
         occurrences all number
    87
    135
    9
    Pharyngitis
         subjects affected / exposed
    13 / 179 (7.26%)
    24 / 263 (9.13%)
    1 / 122 (0.82%)
         occurrences all number
    20
    32
    1
    Rhinitis
         subjects affected / exposed
    6 / 179 (3.35%)
    14 / 263 (5.32%)
    0 / 122 (0.00%)
         occurrences all number
    9
    18
    0
    Upper respiratory tract infection
         subjects affected / exposed
    29 / 179 (16.20%)
    21 / 263 (7.98%)
    2 / 122 (1.64%)
         occurrences all number
    53
    31
    2
    Urinary tract infection
         subjects affected / exposed
    10 / 179 (5.59%)
    12 / 263 (4.56%)
    0 / 122 (0.00%)
         occurrences all number
    12
    21
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    18 / 179 (10.06%)
    14 / 263 (5.32%)
    5 / 122 (4.10%)
         occurrences all number
    18
    17
    5

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2015
    Protocol Amendment 1: introduced the following changes:  The study medication for patients on the 75 mg treatment arm was to be escalated from 75mg s.c. to 150 mg s.c. every 4 weeks for patients whose overall therapeutic response was not fully achieved with the current dose of 75 mg and could improve with a higher dose, as judged by the investigator. The escalation of the study medication could be determined at any site visit. For patients escalated to 150 mg, no dose reduction could be performed at a later time point. Following the Week 52 database lock (DBL) and interim analysis, based on the safety results of studies CAIN457F2305 and CAIN457F2310, the Data Monitoring Committee (DMC) review was no longer required.  Protocol exclusion criterion #6 was changed to “Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU).”  BASDAI 50 response had been recognized as a clinically relevant indicator of therapeutic response to biologic agents in the treatment of AS, and therefore was added as an exploratory endpoint.  The Risks and Benefits section was updated to reflect the latest available information at that time

    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.
    None reported
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA