Spondylitis, Ankylosing
Conditions
Keywords
AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection
Brief summary
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
Interventions
DRUGSecukinumab
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
Placebo to AIN457 (Secukinumab)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. --
Exclusion criteria
pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | 16 weeks | ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum hsCRP | Baseline and 16 weeks | 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 sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time. |
| ASAS 5/6 Response | 16 weeks | ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo. |
| Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Baseline and 16 weeks | BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem), to characterise six clinical domains 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 index was used to assess the efficacy of at least one dose of secukinumab versus placebo. |
| ASAS 40 Response | 16 weeks | ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo. |
| Pre-filled Syringe Possible Hazard | Week 8 and Week 12 | The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits. |
| Prefilled Syringe Patient Satisfaction Assessment | Baseline, weeks 8, 12 and 16 | The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection. |
| ASAS Partial Remission | 16 weeks | 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 of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo. |
| Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Week 8 and Week 12 | Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits. |
Countries
Belgium, Czechia, Germany, Greece, Mexico, Portugal, Russia, Spain, United Kingdom, United States
Participant flow
Recruitment details
Patients were randomized to one of three treatment groups (1:1:1) and planned to be treated for 156 weeks. At Week 16, subjects who were randomized to placebo were re-randomized to secukinumab 150 mg or 300 mg. Patients were enrolled in 54 centers in Germany, Spain, United States, Czech Republic, Belgium, Greece, Mexico, Portugal, Russia and UK.
Pre-assignment details
A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. | 74 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. | 76 |
| Placebo i.v. and s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study. | 76 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Primary Assessment (up to Week 16) | Withdrawal by Subject | 0 | 1 | 3 |
| Week 16 - 156 | Adverse Event | 4 | 2 | 3 |
| Week 16 - 156 | Lack of Efficacy | 3 | 5 | 2 |
| Week 16 - 156 | Lost to Follow-up | 5 | 0 | 0 |
| Week 16 - 156 | No longer requires treatment | 0 | 1 | 0 |
| Week 16 - 156 | Physician Decision | 0 | 1 | 0 |
| Week 16 - 156 | Pregnancy | 0 | 1 | 0 |
| Week 16 - 156 | Withdrawal by Subject | 7 | 3 | 5 |
Baseline characteristics
| Characteristic | Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Placebo i.v. and s.c. | Total |
|---|---|---|---|---|
| Age, Continuous | 42.9 Years STANDARD_DEVIATION 11.11 | 42.1 Years STANDARD_DEVIATION 11.81 | 42.7 Years STANDARD_DEVIATION 11.43 | 42.5 Years STANDARD_DEVIATION 11.41 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 6 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 13 Participants | 12 Participants | 38 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 52 Participants | 58 Participants | 164 Participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 36 Participants | 90 Participants |
| Sex: Female, Male Male | 46 Participants | 50 Participants | 40 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 113 | 0 / 223 | 0 / 75 |
| other Total, other adverse events | 86 / 110 | 89 / 113 | 175 / 223 | 28 / 75 |
| serious Total, serious adverse events | 11 / 110 | 11 / 113 | 22 / 223 | 1 / 75 |
Outcome results
Primary
Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time frame: 16 weeks
Population: FAS - Missing ASAS responses were considered as non-responder
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Responder | 43 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Non-Responder | 31 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Responder | 46 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Non-Responder | 30 Participants |
| Placebo i.v. and s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Responder | 28 Participants |
| Placebo i.v. and s.c. | Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response | Non-Responder | 48 Participants |
p-value: 0.009395% CI: [1.24, 4.69]Regression, Logistic
p-value: 0.003795% CI: [1.38, 5.21]Regression, Logistic
Secondary
ASAS 40 Response
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time frame: 16 weeks
Population: FAS - Missing ASAS responses were considered as non-responder
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS 40 Response | Responder | 30 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS 40 Response | Non-Responder | 44 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS 40 Response | Responder | 32 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS 40 Response | Non-Responder | 44 Participants |
| Placebo i.v. and s.c. | ASAS 40 Response | Responder | 16 Participants |
| Placebo i.v. and s.c. | ASAS 40 Response | Non-Responder | 60 Participants |
p-value: 0.0195% CI: [1.26, 5.35]Regression, Logistic
p-value: 0.005195% CI: [1.36, 5.78]Regression, Logistic
Secondary
ASAS 5/6 Response
ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time frame: 16 weeks
Population: FAS - Missing ASAS responses were considered as non-responder
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS 5/6 Response | Responder | 31 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS 5/6 Response | Non-Responder | 43 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS 5/6 Response | Responder | 30 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS 5/6 Response | Non-Responder | 46 Participants |
| Placebo i.v. and s.c. | ASAS 5/6 Response | Responder | 11 Participants |
| Placebo i.v. and s.c. | ASAS 5/6 Response | Non-Responder | 65 Participants |
p-value: 0.000295% CI: [2.01, 9.92]Regression, Logistic
p-value: 0.000495% CI: [1.89, 9.38]Regression, Logistic
Secondary
ASAS Partial Remission
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 of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time frame: 16 weeks
Population: FAS - Missing ASAS responses were considered as non-responder
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS Partial Remission | Responder | 7 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | ASAS Partial Remission | Non-Responder | 67 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS Partial Remission | Responder | 16 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | ASAS Partial Remission | Non-Responder | 60 Participants |
| Placebo i.v. and s.c. | ASAS Partial Remission | Responder | 1 Participants |
| Placebo i.v. and s.c. | ASAS Partial Remission | Non-Responder | 75 Participants |
p-value: 0.059395% CI: [0.92, 64.42]Regression, Logistic
p-value: 0.004695% CI: [2.49, 150.79]Regression, Logistic
Secondary
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem), to characterise six clinical domains 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 index was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Time frame: Baseline and 16 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Week 16 | 4.451 units on a scale | Standard Deviation 2.5623 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Baseline | 6.958 units on a scale | Standard Deviation 1.3913 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Change from Baseline to Week 16 | -2.548 units on a scale | Standard Deviation 2.4559 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Week 16 | 4.178 units on a scale | Standard Deviation 2.7038 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Baseline | 6.963 units on a scale | Standard Deviation 1.3766 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Change from Baseline to Week 16 | -2.796 units on a scale | Standard Deviation 2.6374 |
| Placebo i.v. and s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Baseline | 6.907 units on a scale | Standard Deviation 1.26 |
| Placebo i.v. and s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Change from Baseline to Week 16 | -1.590 units on a scale | Standard Deviation 2.0084 |
| Placebo i.v. and s.c. | Bath Ankylosing Spondylitis Disease Activity Index / BASDAI | Week 16 | 5.369 units on a scale | Standard Deviation 2.2574 |
p-value: 0.034795% CI: [-1.6, -0.06]Mixed Models Analysis
p-value: 0.001895% CI: [-2, -0.46]Mixed Models Analysis
Secondary
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.
Time frame: Week 8 and Week 12
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Successful Self-administration | 72 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Unsuccessful Self-administration | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Missing | 2 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Successful Self-administration | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Unsuccessful Self-administration | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Successful Self-administration | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Successful Self-administration | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Unsuccessful Self-administration | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Unsuccessful Self-administration | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Missing | 3 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Unsuccessful Self-administration | 1 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Missing | 3 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Missing | 3 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Successful Self-administration | 72 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 8 | Successful Self-administration | 71 Participants |
| Placebo i.v. and s.c. | Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) | Self-administration Week 12 | Unsuccessful Self-administration | 0 Participants |
Secondary
Prefilled Syringe Patient Satisfaction Assessment
The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.
Time frame: Baseline, weeks 8, 12 and 16
Population: Safety Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Self-confidence | 7.51 Points | Standard Deviation 2.388 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Satisfaction with self-injection | 7.67 Points | Standard Deviation 1.734 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Satisfaction with self-injection | 5.34 Points | Standard Deviation 2.692 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Feeling about injections | 8.45 Points | Standard Deviation 1.968 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Satisfaction with self-injection | 7.68 Points | Standard Deviation 1.483 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Satisfaction with self-injection | 7.57 Points | Standard Deviation 1.741 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Feeling about injections | 7.97 Points | Standard Deviation 1.946 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Feeling about injections | 8.15 Points | Standard Deviation 2.337 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Self-confidence | 6.27 Points | Standard Deviation 2.811 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Self-confidence | 7.08 Points | Standard Deviation 2.52 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Feeling about injections | 7.96 Points | Standard Deviation 2.538 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Self-confidence | 7.01 Points | Standard Deviation 2.603 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Self-confidence | 6.66 Points | Standard Deviation 2.855 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Self-confidence | 7.23 Points | Standard Deviation 2.566 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Feeling about injections | 7.99 Points | Standard Deviation 2.269 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Feeling about injections | 7.66 Points | Standard Deviation 2.369 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Satisfaction with self-injection | 7.50 Points | Standard Deviation 1.667 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Self-confidence | 7.28 Points | Standard Deviation 2.231 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Self-confidence | 6.66 Points | Standard Deviation 2.315 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Satisfaction with self-injection | 7.50 Points | Standard Deviation 1.816 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Feeling about injections | 7.93 Points | Standard Deviation 2.201 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Satisfaction with self-injection | 6.12 Points | Standard Deviation 2.429 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Satisfaction with self-injection | 7.82 Points | Standard Deviation 1.933 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Feeling about injections | 7.68 Points | Standard Deviation 2.296 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Satisfaction with self-injection | 7.67 Points | Standard Deviation 1.577 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Feeling about injections | 8.01 Points | Standard Deviation 1.927 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Feeling about injections | 8.24 Points | Standard Deviation 2.082 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Feeling about injections | 8.25 Points | Standard Deviation 1.997 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Feeling about injections | 8.41 Points | Standard Deviation 2.037 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Self-confidence | 6.52 Points | Standard Deviation 2.273 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Self-confidence | 7.41 Points | Standard Deviation 2.198 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Self-confidence | 7.42 Points | Standard Deviation 2.23 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 16: Self-confidence | 7.64 Points | Standard Deviation 2.192 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 8: Satisfaction with self-injection | 7.39 Points | Standard Deviation 2.002 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 12: Satisfaction with self-injection | 7.46 Points | Standard Deviation 1.78 |
| Placebo i.v. and s.c. | Prefilled Syringe Patient Satisfaction Assessment | Week 0: Satisfaction with self-injection | 5.30 Points | Standard Deviation 2.694 |
Secondary
Pre-filled Syringe Possible Hazard
The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.
Time frame: Week 8 and Week 12
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Yes | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | No | 72 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Yes | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Yes | 2 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | No | 71 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Yes | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Missing | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Yes | 5 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | No | 68 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | No | 73 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Missing | 3 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Yes | 4 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | No | 71 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Yes | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | No | 74 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Missing | 1 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Yes | 0 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | No | 75 Participants |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Missing | 1 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | No | 69 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was allergic reaction to device noticed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was pain increased due to bent needle? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was pain increased due to bent needle? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Yes | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was allergic reaction to device noticed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any other problem observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was less than the full dose administered | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was there breakage of device observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a critical area? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Yes | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was any other problem observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was any part of the device swallowed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | No | 69 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was needle stick in a critical area? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was needle stick in a non-critical area? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was swallowing of debris observed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8:Was swallowing of debris observed? | Yes | 0 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was needle stick in a non-critical area? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was any part of the device swallowed? | No | 72 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 8: Was there breakage of device observed? | Missing | 3 Participants |
| Placebo i.v. and s.c. | Pre-filled Syringe Possible Hazard | Week 12: Was less than the full dose administered? | Yes | 0 Participants |
Secondary
Serum hsCRP
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 sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.
Time frame: Baseline and 16 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Serum hsCRP | Week 16 | 7.68 mg/L | Standard Deviation 13.277 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Serum hsCRP | Baseline | 15.79 mg/L | Standard Deviation 21.075 |
| Secukinumab 10 mg/kg i.v. / 150 mg s.c. | Serum hsCRP | Change from Baseline to Week 16 | -8.06 mg/L | Standard Deviation 21.132 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Serum hsCRP | Week 16 | 4.34 mg/L | Standard Deviation 5.433 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Serum hsCRP | Baseline | 11.08 mg/L | Standard Deviation 13.285 |
| Secukinumab 10 mg/kg i.v. / 300 mg s.c. | Serum hsCRP | Change from Baseline to Week 16 | -6.75 mg/L | Standard Deviation 13.778 |
| Placebo i.v. and s.c. | Serum hsCRP | Baseline | 13.91 mg/L | Standard Deviation 19.999 |
| Placebo i.v. and s.c. | Serum hsCRP | Change from Baseline to Week 16 | 0.57 mg/L | Standard Deviation 11.629 |
| Placebo i.v. and s.c. | Serum hsCRP | Week 16 | 15.34 mg/L | Standard Deviation 21.694 |
p-value: <0.000195% CI: [0.38, 0.68]Mixed Models Analysis
p-value: <0.000195% CI: [0.33, 0.6]Mixed Models Analysis