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Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (FUTURE5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404350
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : June 28, 2019
Last Update Posted : April 20, 2020
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 Psoriatic Arthritis
Intervention Biological: Secukinumab
Enrollment 997
Recruitment Details Study was conducted at 173 centers in 28 countries.
Pre-assignment Details 996 were randomized and dosed, of which 932 participants completed 24 weeks of treatment. Out of the 64 participants who discontinued the most common reasons were participant/guardian decision (32) and adverse events (16).
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks. Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100. Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks. Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Period Title: Overall Study
Started 222 220 222 332
Completed [1] 207 214 216 295
Not Completed 15 6 6 37
Reason Not Completed
Adverse Event             2             2             3             9
Lack of Efficacy             3             1             0             3
Lost to Follow-up             2             0             0             1
Physician Decision             1             0             0             2
Pregnancy             0             0             0             1
Withdrawal by Subject             7             3             3             19
Due to Non-compliance with treatment             0             0             0             1
Due to Technical problems             0             0             0             1
[1]
Completed Randomisation phase (up to week 24).
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo Total
Hide Arm/Group Description Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks. Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100. Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks. Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks. Total of all reporting groups
Overall Number of Baseline Participants 222 220 222 332 996
Hide Baseline Analysis Population Description
The randomized set was defined as all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
48.8  (11.82) 48.4  (12.87) 48.9  (12.80) 49.0  (12.12) 48.8  (12.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
Female
102
  45.9%
109
  49.5%
114
  51.4%
171
  51.5%
496
  49.8%
Male
120
  54.1%
111
  50.5%
108
  48.6%
161
  48.5%
500
  50.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
Hispanic or Latino
25
  11.3%
30
  13.6%
31
  14.0%
51
  15.4%
137
  13.8%
Not Hispanic or Latino
180
  81.1%
160
  72.7%
174
  78.4%
251
  75.6%
765
  76.8%
Unknown or Not Reported
17
   7.7%
30
  13.6%
17
   7.7%
30
   9.0%
94
   9.4%
Subjects with psoriasis of hands and feet  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
Yes
133
  59.9%
135
  61.4%
127
  57.2%
174
  52.4%
569
  57.1%
No
89
  40.1%
85
  38.6%
95
  42.8%
158
  47.6%
427
  42.9%
Subjects with psoriasis of nail  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
Yes
153
  68.9%
135
  61.4%
144
  64.9%
231
  69.6%
663
  66.6%
No
69
  31.1%
85
  38.6%
78
  35.1%
101
  30.4%
333
  33.4%
Subjects with psoriasis ≥ 3% of BSA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 220 participants 222 participants 332 participants 996 participants
Yes
117
  52.7%
125
  56.8%
110
  49.5%
162
  48.8%
514
  51.6%
No
105
  47.3%
95
  43.2%
112
  50.5%
170
  51.2%
482
  48.4%
1.Primary Outcome
Title Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16
Hide Description ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in Full Analysis Set (FAS) population defined as all randomized participants assigned to study treatment. Following the intent-to-treat principle, participants were analyzed according to treatment assigned at randomization by actual anti-Tumor Necrosis Factor (TNF) status. Missing responses were imputed as non-responders.
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 222 220 222 332
Measure Type: Number
Unit of Measure: percentage of participants
59.5 55.5 62.6 27.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load, Placebo
Comments Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.02
Confidence Interval (2-Sided) 95%
2.78 to 5.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load, Placebo
Comments Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.38
Confidence Interval (2-Sided) 95%
2.35 to 4.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load, Placebo
Comments Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.58
Confidence Interval (2-Sided) 95%
3.16 to 6.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))
Hide Description PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population with a measurement that could be evaluated. Participants in placebo group, rescued at Week 16 were also extrapolated (i.e. treated as missing at Week 24).
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 222 220 222 332
Mean (Standard Deviation)
Unit of Measure: Mean Sharp Score
baseline Number Analyzed 210 participants 213 participants 217 participants 296 participants
15.25  (37.098) 13.50  (25.636) 12.90  (23.781) 14.95  (38.236)
change Number Analyzed 210 participants 213 participants 217 participants 296 participants
-0.10  (2.872) 0.13  (1.222) 0.02  (1.336) 0.50  (1.708)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load, Placebo
Comments Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Non-parametric ANCOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean
Estimated Value -0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments *For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load, Placebo
Comments Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Non-parametric ANCOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean
Estimated Value -0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments *For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load, Placebo
Comments Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Non-parametric ANCOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Mean
Estimated Value -0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean
3.Secondary Outcome
Title Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response
Hide Description The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 117 125 110 162
Measure Type: Count of Participants
Unit of Measure: Participants
68
  58.1%
75
  60.0%
77
  70.0%
20
  12.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.15
Confidence Interval (2-Sided) 95%
5.52 to 18.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.66
Confidence Interval (2-Sided) 95%
6.37 to 21.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.06
Confidence Interval (2-Sided) 95%
9.56 to 34.12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response
Hide Description The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 117 125 110 162
Measure Type: Count of Participants
Unit of Measure: Participants
37
  31.6%
46
  36.8%
59
  53.6%
15
   9.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments

Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.

Missing responses are imputed as non-responders.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.51
Confidence Interval (2-Sided) 95%
2.31 to 8.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
Comments

Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.

Missing responses are imputed as non-responders.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.14
Confidence Interval (2-Sided) 95%
3.18 to 11.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments

Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.

Missing responses are imputed as non-responders.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.55
Confidence Interval (2-Sided) 95%
6.43 to 24.48
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Count and Percentage of Patients Achieving an ACR50 Response
Hide Description ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 222 220 222 332
Measure Type: Count of Participants
Unit of Measure: Participants
71
  32.0%
79
  35.9%
88
  39.6%
27
   8.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 5.37
Confidence Interval (2-Sided) 95%
3.30 to 8.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.37
Confidence Interval (2-Sided) 95%
3.93 to 10.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.43
Confidence Interval (2-Sided) 95%
4.61 to 12.00
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in HAQ-DI© Score
Hide Description The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 211 210 211 300
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-0.45  (0.035) -0.44  (0.035) -0.55  (0.035) -0.21  (0.029)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment contrast in LS mean (Change)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.32 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
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 LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment Contrast in LS mean (Change)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.32 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
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 LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment Contrast inj LS mean (Change)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.42 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))
Hide Description

The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline.

Scores range from 0 (no difficulty) to 3 (unable to do)

Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 210 208 209 297
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.29  (0.074) -1.29  (0.075) -1.49  (0.074) -0.63  (0.062)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment contrast in LS mean (Change)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.85 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
Comments Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment Contrast in LS Mean (Change)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.85 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)
Method of Estimation Estimation Parameter Treatment contrast in LS mean (Change)
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.05 to -0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.096
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline
Hide Description The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enthesitis subset: The enthesitis subset included all FAS patients who had enthesitis at baseline.
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 129 141 140 192
Measure Type: Count of Participants
Unit of Measure: Participants
75
  58.1%
64
  45.4%
62
  44.3%
124
  64.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2250
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.47 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.29 to 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.28 to 0.69
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline
Hide Description The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dactylitis subset: The dactylitis subset included all FAS patients who had dactylitis at baseline.
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Placebo
Hide Arm/Group Description:
Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.
Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.
Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.
Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Number of Participants Analyzed 103 80 82 124
Measure Type: Count of Participants
Unit of Measure: Participants
45
  43.7%
34
  42.5%
28
  34.1%
84
  67.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg Without Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.22 to 0.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 150 mg With Load
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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.19 to 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Secukinumab 300 mg With Load
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.13 to 0.44
Estimation Comments [Not Specified]
Time Frame AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks
Adverse Event Reporting Description An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
 
Arm/Group Title Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
Hide Arm/Group Description Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline. Participants received secukinumab matching placebo (2*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks. Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100. Participants were s.c. administered with 300 mg of secukinumab as 2*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks. Participants were s.c. administered with secukinumab and secukinumab matching placebo at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100. Participants were s.c. administered with secukinumab matching placebo (2*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
All-Cause Mortality
Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/222 (0.00%)   0/220 (0.00%)   0/222 (0.00%)   0/822 (0.00%)   0/332 (0.00%) 
Hide Serious Adverse Events
Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/222 (2.70%)   9/220 (4.09%)   7/222 (3.15%)   25/822 (3.04%)   12/332 (3.61%) 
Blood and lymphatic system disorders           
Thrombocytopenia  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Cardiac disorders           
Coronary artery disease  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Myocardial infarction  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Gastrointestinal disorders           
Colitis ulcerative  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Crohn's disease  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Diverticulum  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Rectal haemorrhage  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
General disorders           
Non-cardiac chest pain  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Immune system disorders           
Anaphylactic reaction  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Infections and infestations           
Cellulitis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  2/332 (0.60%) 
Otitis externa  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Tonsillitis  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Typhoid fever  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Viral infection  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Injury, poisoning and procedural complications           
Ankle fracture  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Concussion  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Foreign body  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Hip fracture  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Humerus fracture  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Road traffic accident  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Tibia fracture  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Ulna fracture  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Investigations           
Computerised tomogram thorax abnormal  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthritis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Chondropathy  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Musculoskeletal chest pain  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Rotator cuff syndrome  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Synovitis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Malignant melanoma  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Nervous system disorders           
Carotid artery stenosis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Polyneuropathy  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Sciatica  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Transient ischaemic attack  1  0/222 (0.00%)  0/220 (0.00%)  1/222 (0.45%)  1/822 (0.12%)  0/332 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Ectopic pregnancy  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Psychiatric disorders           
Suicidal ideation  1  0/222 (0.00%)  1/220 (0.45%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Renal and urinary disorders           
Renal colic  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Pulmonary embolism  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
Skin and subcutaneous tissue disorders           
Psoriasis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Vascular disorders           
Circulatory collapse  1  1/222 (0.45%)  0/220 (0.00%)  0/222 (0.00%)  1/822 (0.12%)  0/332 (0.00%) 
Deep vein thrombosis  1  0/222 (0.00%)  0/220 (0.00%)  0/222 (0.00%)  0/822 (0.00%)  1/332 (0.30%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Secukinumab 150 mg Without Load Secukinumab 150 mg With Load Secukinumab 300 mg With Load Secukinumab Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   95/222 (42.79%)   82/220 (37.27%)   83/222 (37.39%)   275/822 (33.45%)   127/332 (38.25%) 
Blood and lymphatic system disorders           
Leukopenia  1  1/222 (0.45%)  1/220 (0.45%)  6/222 (2.70%)  11/822 (1.34%)  1/332 (0.30%) 
Gastrointestinal disorders           
Diarrhoea  1  7/222 (3.15%)  4/220 (1.82%)  9/222 (4.05%)  21/822 (2.55%)  22/332 (6.63%) 
Nausea  1  7/222 (3.15%)  4/220 (1.82%)  3/222 (1.35%)  14/822 (1.70%)  12/332 (3.61%) 
Vomiting  1  3/222 (1.35%)  6/220 (2.73%)  2/222 (0.90%)  12/822 (1.46%)  2/332 (0.60%) 
General disorders           
Fatigue  1  4/222 (1.80%)  4/220 (1.82%)  4/222 (1.80%)  12/822 (1.46%)  8/332 (2.41%) 
Infections and infestations           
Bronchitis  1  3/222 (1.35%)  1/220 (0.45%)  8/222 (3.60%)  12/822 (1.46%)  2/332 (0.60%) 
Influenza  1  2/222 (0.90%)  4/220 (1.82%)  5/222 (2.25%)  12/822 (1.46%)  3/332 (0.90%) 
Oral herpes  1  3/222 (1.35%)  0/220 (0.00%)  5/222 (2.25%)  8/822 (0.97%)  4/332 (1.20%) 
Rhinitis  1  2/222 (0.90%)  2/220 (0.91%)  7/222 (3.15%)  11/822 (1.34%)  3/332 (0.90%) 
Upper respiratory tract infection  1  14/222 (6.31%)  17/220 (7.73%)  7/222 (3.15%)  38/822 (4.62%)  11/332 (3.31%) 
Urinary tract infection  1  6/222 (2.70%)  8/220 (3.64%)  6/222 (2.70%)  20/822 (2.43%)  8/332 (2.41%) 
Viral upper respiratory tract infection  1  13/222 (5.86%)  15/220 (6.82%)  14/222 (6.31%)  44/822 (5.35%)  29/332 (8.73%) 
Injury, poisoning and procedural complications           
Contusion  1  3/222 (1.35%)  5/220 (2.27%)  2/222 (0.90%)  10/822 (1.22%)  1/332 (0.30%) 
Fall  1  5/222 (2.25%)  1/220 (0.45%)  0/222 (0.00%)  6/822 (0.73%)  2/332 (0.60%) 
Metabolism and nutrition disorders           
Dyslipidaemia  1  8/222 (3.60%)  4/220 (1.82%)  8/222 (3.60%)  23/822 (2.80%)  11/332 (3.31%) 
Hypercholesterolaemia  1  8/222 (3.60%)  9/220 (4.09%)  3/222 (1.35%)  20/822 (2.43%)  2/332 (0.60%) 
Hyperlipidaemia  1  1/222 (0.45%)  5/220 (2.27%)  3/222 (1.35%)  9/822 (1.09%)  2/332 (0.60%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  3/222 (1.35%)  4/220 (1.82%)  4/222 (1.80%)  12/822 (1.46%)  10/332 (3.01%) 
Back pain  1  8/222 (3.60%)  4/220 (1.82%)  4/222 (1.80%)  16/822 (1.95%)  12/332 (3.61%) 
Psoriatic arthropathy  1  3/222 (1.35%)  3/220 (1.36%)  0/222 (0.00%)  7/822 (0.85%)  7/332 (2.11%) 
Nervous system disorders           
Headache  1  8/222 (3.60%)  9/220 (4.09%)  5/222 (2.25%)  23/822 (2.80%)  13/332 (3.92%) 
Psychiatric disorders           
Anxiety  1  1/222 (0.45%)  5/220 (2.27%)  0/222 (0.00%)  6/822 (0.73%)  1/332 (0.30%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  7/222 (3.15%)  2/220 (0.91%)  4/222 (1.80%)  14/822 (1.70%)  6/332 (1.81%) 
Oropharyngeal pain  1  5/222 (2.25%)  5/220 (2.27%)  5/222 (2.25%)  16/822 (1.95%)  6/332 (1.81%) 
Skin and subcutaneous tissue disorders           
Pruritus  1  2/222 (0.90%)  11/220 (5.00%)  3/222 (1.35%)  16/822 (1.95%)  4/332 (1.20%) 
Psoriasis  1  3/222 (1.35%)  3/220 (1.36%)  3/222 (1.35%)  11/822 (1.34%)  12/332 (3.61%) 
Vascular disorders           
Hypertension  1  9/222 (4.05%)  5/220 (2.27%)  8/222 (3.60%)  22/822 (2.68%)  10/332 (3.01%) 
1
Term from vocabulary, MedDRA (20.0)
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 (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: +1 (862) 778-8300
EMail: Novartis.email@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02404350    
Other Study ID Numbers: CAIN457F2342
2015-000050-38 ( EudraCT Number )
02404350 ( Registry Identifier: clinicaltrials.gov )
First Submitted: March 16, 2015
First Posted: March 31, 2015
Results First Submitted: July 19, 2018
Results First Posted: June 28, 2019
Last Update Posted: April 20, 2020