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16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE2)

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ClinicalTrials.gov Identifier: NCT01649375
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anklyosing Spondylitis
Interventions Drug: Secukinumab (75 mg)
Drug: Placebo
Drug: Secukinumab (150 mg)
Enrollment 219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo Placebo - Secukinumab 75 mg Placebo - Secukinumab 150 mg
Hide Arm/Group Description Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16 Placebo patients re-randomized to secukinumab 75 mg subcutaneous injection every 4 weeks starting from week 16. Placebo patients re-randomized to secukinumab 150 mg subcutaneous injection every 4 weeks starting from week 16.
Period Title: Up to Week 16
Started 73 72 74 0 0
Completed 68 66 66 0 0
Not Completed 5 6 8 0 0
Reason Not Completed
Adverse Event             2             5             4             0             0
Lack of Efficacy             0             0             1             0             0
Physician Decision             0             0             1             0             0
Withdrawal by Subject             2             1             2             0             0
Death             1             0             0             0             0
Period Title: Week 16 up to Week 260
Started 68 66 0 32 34
Completed 48 53 0 20 29
Not Completed 20 13 0 12 5
Reason Not Completed
Lack of Efficacy             7             4             0             4             2
Non-compliance             0             1             0             1             0
Physician Decision             0             2             0             0             0
Technical issues             0             1             0             1             0
Withdrawal by Subject             7             2             0             3             1
Death             1             1             0             0             0
Adverse Event             5             2             0             3             2
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo Total
Hide Arm/Group Description Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16 Total of all reporting groups
Overall Number of Baseline Participants 73 72 74 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 74 participants 219 participants
< 65 years 70 70 72 212
>= 65 to 74 years 2 2 1 5
>= 75 years 1 0 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 74 participants 219 participants
Female
22
  30.1%
26
  36.1%
18
  24.3%
66
  30.1%
Male
51
  69.9%
46
  63.9%
56
  75.7%
153
  69.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 74 participants 219 participants
White 70 69 70 209
Asian 3 2 4 9
American Indian or Alaska Native 0 1 0 1
1.Primary Outcome
Title Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16
Hide Description ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Measure Type: Number
Unit of Measure: percentage of participants
41.1 61.1 28.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0967
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
0.90 to 3.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.38
Confidence Interval (2-Sided) 95%
2.14 to 8.96
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response
Hide Description

ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain.

ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Measure Type: Number
Unit of Measure: percentage of participants
26.0 36.1 10.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0194
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.99
Confidence Interval (2-Sided) 95%
1.19 to 7.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0004
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.07
Confidence Interval (2-Sided) 95%
2.06 to 12.44
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline at Week 16 in Serum hsCRP
Hide Description The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
0.61  (1.103) 0.55  (1.104) 1.13  (1.105)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.41 to 0.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.37 to 0.64
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16
Hide Description ASAS 5/6 response is a validated composite assessment, reflecting the percentage of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Measure Type: Number
Unit of Measure: percentage of participants
34.2 43.1 8.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.13
Confidence Interval (2-Sided) 95%
2.31 to 16.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.15
Confidence Interval (2-Sided) 95%
3.47 to 24.12
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Hide Description BASDAI is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.92  (0.249) -2.19  (0.248) -0.85  (0.252)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-1.77 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.353
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-2.04 to -0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.353
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)
Hide Description Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
4.77  (0.798) 6.06  (0.784) 1.92  (0.786)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0110
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.84
Confidence Interval (2-Sided) 95%
0.66 to 5.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.108
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.14
Confidence Interval (2-Sided) 95%
1.96 to 6.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.105
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline at Week 16 in ASQoL
Hide Description ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-3.33  (0.537) -4.00  (0.528) -1.37  (0.530)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.96
Confidence Interval (2-Sided) 95%
-3.43 to -0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.748
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.63
Confidence Interval (2-Sided) 95%
-4.09 to -1.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.743
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving ASAS Partial Remission at Week 16
Hide Description ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time Frame Baseline up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 75 mg Secukinumab 150 mg Placebo
Hide Arm/Group Description:
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks up to week 16
Overall Number of Participants Analyzed 73 72 74
Measure Type: Number
Unit of Measure: percentage of participants
15.1 13.9 4.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0325
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.28
Confidence Interval (2-Sided) 95%
1.13 to 16.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0471
Comments [Not Specified]
Method Regression, Logistic
Comments Missing ASAS responses considered nonresponders
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.91
Confidence Interval (2-Sided) 95%
1.02 to 15.01
Estimation Comments [Not Specified]
Time Frame Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to 5.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Any Secukinumab 75 mg Any Secukinumab 150 mg Placebo
Hide Arm/Group Description Includes patients originally randomized to secukinumab 75 mg at baseline and placebo patients who were re-randomized to secukinumab 75 mg at week 16 (AEs occurring after re-randomization). Includes patients originally randomized to secukinumab 150 mg at baseline, placebo patients re-randomized to secukinumab 150 mg at Week 16 (AEs occuring after re-randomization) and patients who up-titrated from secukinumab 75 mg to 150 mg (AEs occurring after up-titration). Includes patients originally randomized to Placebo for AEs until the time of re-randomization (Week 16) to Secukinumab
All-Cause Mortality
Any Secukinumab 75 mg Any Secukinumab 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/105 (1.90%)   1/155 (0.65%)   0/74 (0.00%) 
Hide Serious Adverse Events
Any Secukinumab 75 mg Any Secukinumab 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/105 (23.81%)   31/155 (20.00%)   4/74 (5.41%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Cardiac disorders       
Acute coronary syndrome  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Acute myocardial infarction  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Angina pectoris  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Atrioventricular block complete  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Coronary artery stenosis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Myocardial infarction  1  2/105 (1.90%)  1/155 (0.65%)  0/74 (0.00%) 
Eye disorders       
Iridocyclitis  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Iritis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Gastrointestinal disorders       
Abdominal hernia  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Abdominal pain upper  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Anal fissure  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Colitis ischaemic  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Colitis microscopic  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Colitis ulcerative  1  1/105 (0.95%)  1/155 (0.65%)  0/74 (0.00%) 
Crohn's disease  1  2/105 (1.90%)  2/155 (1.29%)  0/74 (0.00%) 
Diarrhoea  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Incarcerated hiatus hernia  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
General disorders       
Drug ineffective  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Cholelithiasis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Immune system disorders       
Sarcoidosis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Infections and infestations       
Anal abscess  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Arthritis bacterial  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Erysipelas  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Febrile infection  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Gallbladder abscess  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Gastroenteritis salmonella  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Groin abscess  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Influenza  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Meningitis viral  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Pharyngitis  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Pneumonia  1  2/105 (1.90%)  2/155 (1.29%)  0/74 (0.00%) 
Postoperative wound infection  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Injury, poisoning and procedural complications       
Concussion  1  0/105 (0.00%)  0/155 (0.00%)  1/74 (1.35%) 
Hip fracture  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Lower limb fracture  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Lumbar vertebral fracture  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Multiple injuries  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Rib fracture  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Spinal compression fracture  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Spinal cord injury cervical  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Splenic rupture  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Investigations       
Hepatic enzyme increased  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Musculoskeletal and connective tissue disorders       
Ankylosing spondylitis  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Arthritis  1  0/105 (0.00%)  0/155 (0.00%)  1/74 (1.35%) 
Back pain  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Costochondritis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Foot deformity  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Intervertebral disc protrusion  1  0/105 (0.00%)  1/155 (0.65%)  1/74 (1.35%) 
Osteoarthritis  1  1/105 (0.95%)  1/155 (0.65%)  0/74 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Glioblastoma  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Intraductal proliferative breast lesion  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Malignant melanoma  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Paraganglion neoplasm  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Superficial spreading melanoma stage unspecified  1  0/105 (0.00%)  0/155 (0.00%)  1/74 (1.35%) 
Nervous system disorders       
Carpal tunnel syndrome  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Headache  1  0/105 (0.00%)  2/155 (1.29%)  0/74 (0.00%) 
Ischaemic stroke  1  0/105 (0.00%)  2/155 (1.29%)  0/74 (0.00%) 
Quadriparesis  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Quadriplegia  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Transient ischaemic attack  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Psychiatric disorders       
Depression  1  0/105 (0.00%)  0/155 (0.00%)  1/74 (1.35%) 
Renal and urinary disorders       
Nephrotic syndrome  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Stress urinary incontinence  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Reproductive system and breast disorders       
Vaginal haemorrhage  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Nasal septum deviation  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Respiratory arrest  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Sleep apnoea syndrome  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Vascular disorders       
Haematoma  1  0/105 (0.00%)  1/155 (0.65%)  0/74 (0.00%) 
Peripheral arterial occlusive disease  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
Thrombophlebitis superficial  1  1/105 (0.95%)  0/155 (0.00%)  0/74 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Any Secukinumab 75 mg Any Secukinumab 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   76/105 (72.38%)   99/155 (63.87%)   26/74 (35.14%) 
Gastrointestinal disorders       
Diarrhoea  1  9/105 (8.57%)  17/155 (10.97%)  1/74 (1.35%) 
General disorders       
Fatigue  1  4/105 (3.81%)  5/155 (3.23%)  5/74 (6.76%) 
Infections and infestations       
Bronchitis  1  15/105 (14.29%)  14/155 (9.03%)  1/74 (1.35%) 
Gastroenteritis  1  6/105 (5.71%)  13/155 (8.39%)  1/74 (1.35%) 
Influenza  1  13/105 (12.38%)  14/155 (9.03%)  0/74 (0.00%) 
Nasopharyngitis  1  30/105 (28.57%)  35/155 (22.58%)  3/74 (4.05%) 
Oral herpes  1  6/105 (5.71%)  8/155 (5.16%)  0/74 (0.00%) 
Pharyngitis  1  6/105 (5.71%)  3/155 (1.94%)  0/74 (0.00%) 
Rhinitis  1  6/105 (5.71%)  5/155 (3.23%)  1/74 (1.35%) 
Sinusitis  1  5/105 (4.76%)  8/155 (5.16%)  1/74 (1.35%) 
Upper respiratory tract infection  1  13/105 (12.38%)  16/155 (10.32%)  2/74 (2.70%) 
Urinary tract infection  1  5/105 (4.76%)  9/155 (5.81%)  2/74 (2.70%) 
Metabolism and nutrition disorders       
Hyperlipidaemia  1  5/105 (4.76%)  8/155 (5.16%)  1/74 (1.35%) 
Musculoskeletal and connective tissue disorders       
Ankylosing spondylitis  1  6/105 (5.71%)  6/155 (3.87%)  1/74 (1.35%) 
Arthralgia  1  8/105 (7.62%)  10/155 (6.45%)  2/74 (2.70%) 
Back pain  1  7/105 (6.67%)  13/155 (8.39%)  2/74 (2.70%) 
Bursitis  1  6/105 (5.71%)  4/155 (2.58%)  0/74 (0.00%) 
Musculoskeletal pain  1  7/105 (6.67%)  8/155 (5.16%)  0/74 (0.00%) 
Osteoarthritis  1  6/105 (5.71%)  4/155 (2.58%)  1/74 (1.35%) 
Pain in extremity  1  2/105 (1.90%)  11/155 (7.10%)  1/74 (1.35%) 
Nervous system disorders       
Dizziness  1  2/105 (1.90%)  3/155 (1.94%)  4/74 (5.41%) 
Headache  1  9/105 (8.57%)  15/155 (9.68%)  6/74 (8.11%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/105 (4.76%)  11/155 (7.10%)  1/74 (1.35%) 
Oropharyngeal pain  1  4/105 (3.81%)  8/155 (5.16%)  2/74 (2.70%) 
Skin and subcutaneous tissue disorders       
Rash  1  6/105 (5.71%)  4/155 (2.58%)  1/74 (1.35%) 
Vascular disorders       
Hypertension  1  9/105 (8.57%)  15/155 (9.68%)  0/74 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01649375    
Other Study ID Numbers: CAIN457F2310
2012-000046-35 ( EudraCT Number )
First Submitted: July 20, 2012
First Posted: July 25, 2012
Results First Submitted: July 24, 2019
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019