Non-radiographic Spondyloarthritis
Conditions
Keywords
non-radiographic spondyloarthritis, axial spondyloarthritis, Ankylosing Spondylitis
Brief summary
The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208
Detailed description
Patients were randomized to one of three treatment groups (1:1:1) in the core phase: * Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4 * Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4 * Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment. At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase: * Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks; * Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks. Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner. \- Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label. Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.
Interventions
DRUGSecukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
DRUGPlacebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This was a randomized, double-blind, placebo-controlled study. Approximately 555 patients were randomized to one of three treatment groups (secukinumab 150 mg Load, secukinumab 150 mg No Load or placebo in a ratio of 1:1:1): * Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. prefilled syringe (PFS) at baseline (BSL), Weeks 1, 2 and 3, followed by administration every four weeks starting at Week 4 * Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, placebo at Weeks 1, 2 and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4 * Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria * objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein) * active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index \>=4 cm * Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline * Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline * Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response * Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response
Exclusion criteria
* Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally * Inability or unwillingness to undergo MRI * Chest X-ray or MRI with evidence of ongoing infectious or malignant process * Patients taking high potency opioid analgesics * Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor * Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 | Week 16 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. |
| The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52 | Week 52 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response | Week 16 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity. |
| The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR) | Week 16 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity. |
| Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline and Week 16 | The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity. |
| The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 16 and 52 | The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity. |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline and Week 16 | The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating no problem and 10 indicating worst problem), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity. |
| Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 | Baseline and Week 16 | The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is at the moment, and the measure requires approximately 6 minutes to complete. |
| The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | Week 16 and week 52 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. |
| The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease | Week 52 | Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1) |
| Change in High Sensitivity C-reactive Protein | Baseline and Week 16 | High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study. |
| Change in Short Form-36 Physical Component Summary (SF-36 PCS) | Baseline and Week 16 | The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement. |
| Change in Sacroiliac Joint Edema - Week 16 | Baseline and Week 16 | Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24. |
| Change in Sacroiliac Joint Edema - Week 52 | Baseline and Week 52 | Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24. |
| Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52 | Baseline and Week 52 | The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is at the moment, and the measure requires approximately 6 minutes to complete. Summary statistics are presented for participants (n) without intercurrent events. |
| The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response | Week 16 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. |
Countries
Australia, Austria, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
A total of 1583 patients were screened for this study, of which 555 patients (35.1%) were randomized. Overall, 1028 patients (64.9%) discontinued prior to screening phase completion, most due to screen failure (1000 patients, 63.2%).
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab, Load, Core Phase AIN457 150 mg s.c. load, Core Phase | 185 |
| Secukinumab, No Load, Core Phase AIN457 150 mg s.c. no load, Core Phase | 184 |
| Placebo, Core Phase Placebo s.c., Core Phase | 186 |
| Total | 555 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Extension Phase From wk 104 to wk 208 | Adverse Event | 0 | 0 | 0 | 1 | 4 | 1 |
| Extension Phase From wk 104 to wk 208 | Lack of Efficacy | 0 | 0 | 0 | 1 | 1 | 3 |
| Extension Phase From wk 104 to wk 208 | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Extension Phase From wk 104 to wk 208 | Non-compliance with study treatment | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension Phase From wk 104 to wk 208 | Physician Decision | 0 | 0 | 0 | 1 | 1 | 0 |
| Extension Phase From wk 104 to wk 208 | Withdrawal by Subject | 0 | 0 | 0 | 6 | 8 | 2 |
| Up to Week 104 | Adverse Event | 7 | 11 | 5 | 0 | 0 | 0 |
| Up to Week 104 | Lack of Efficacy | 13 | 12 | 11 | 0 | 0 | 0 |
| Up to Week 104 | Lost to Follow-up | 2 | 3 | 1 | 0 | 0 | 0 |
| Up to Week 104 | Physician Decision | 1 | 2 | 3 | 0 | 0 | 0 |
| Up to Week 104 | Pregnancy | 0 | 2 | 1 | 0 | 0 | 0 |
| Up to Week 104 | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Up to Week 104 | Pt completed wk 52. Withdrawal by subject at wk 52. | 0 | 1 | 0 | 0 | 0 | 0 |
| Up to Week 104 | Withdrawal by Subject | 15 | 10 | 16 | 0 | 0 | 0 |
| Up to Week 24 | Adverse Event | 2 | 4 | 2 | 0 | 0 | 0 |
| Up to Week 24 | Lack of Efficacy | 2 | 1 | 2 | 0 | 0 | 0 |
| Up to Week 24 | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 0 |
| Up to Week 24 | Physician Decision | 1 | 0 | 1 | 0 | 0 | 0 |
| Up to Week 24 | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Up to Week 24 | Withdrawal by Subject | 4 | 1 | 5 | 0 | 0 | 0 |
| Up to Week 52 | Adverse Event | 4 | 5 | 3 | 0 | 0 | 0 |
| Up to Week 52 | Lack of Efficacy | 10 | 7 | 11 | 0 | 0 | 0 |
| Up to Week 52 | Lost to Follow-up | 1 | 1 | 1 | 0 | 0 | 0 |
| Up to Week 52 | Physician Decision | 1 | 1 | 2 | 0 | 0 | 0 |
| Up to Week 52 | Pregnancy | 0 | 2 | 0 | 0 | 0 | 0 |
| Up to Week 52 | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Up to Week 52 | Withdrawal by Subject | 12 | 3 | 9 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Secukinumab, Load, Core Phase | Secukinumab, No Load, Core Phase | Placebo, Core Phase | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants | 180 Participants | 183 Participants | 546 Participants |
| Age, Continuous | 39.1 Years STANDARD_DEVIATION 11.45 | 39.8 Years STANDARD_DEVIATION 11.68 | 39.3 Years STANDARD_DEVIATION 11.47 | 39.4 Years STANDARD_DEVIATION 11.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 8 Participants | 7 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants | 162 Participants | 161 Participants | 488 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 14 Participants | 18 Participants | 43 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 8 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 7 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 176 Participants | 165 Participants | 167 Participants | 508 Participants |
| Sex: Female, Male Female | 105 Participants | 100 Participants | 95 Participants | 300 Participants |
| Sex: Female, Male Male | 80 Participants | 84 Participants | 91 Participants | 255 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 / 543 | 0 / 254 | 0 / 543 | 0 / 186 |
| other Total, other adverse events | 320 / 543 | 74 / 254 | 335 / 543 | 67 / 186 |
| serious Total, serious adverse events | 48 / 543 | 11 / 254 | 58 / 543 | 8 / 186 |
Outcome results
Primary
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
Time frame: Week 16
Population: Subset of TNF naive patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 | 68 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 | 70 Participants |
| Placebo, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 | 50 Participants |
Comparison: week 16p-value: 0.019795% CI: [1.09, 2.7]Regression, Logistic
Comparison: week 16p-value: 0.014695% CI: [1.12, 2.76]Regression, Logistic
Primary
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
Time frame: Week 52
Population: Subset of TNF naive patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52 | 58 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52 | 66 Participants |
| Placebo, Core Phase | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52 | 34 Participants |
Comparison: week 52p-value: 0.001795% CI: [1.35, 3.63]Regression, Logistic
Comparison: week 52p-value: <0.000195% CI: [1.64, 4.36]Regression, Logistic
Secondary
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is at the moment, and the measure requires approximately 6 minutes to complete.
Time frame: Baseline and Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 | -3.45 Scores on a scale | Standard Error 0.408 |
| Secukinumab, No Load, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 | -3.62 Scores on a scale | Standard Error 0.414 |
| Placebo, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16 | -1.84 Scores on a scale | Standard Error 0.421 |
Comparison: week 16p-value: 0.000895% CI: [-2.54, -0.67]MMRM
Comparison: week 16p-value: 0.000295% CI: [-2.72, -0.84]MMRM
Secondary
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is at the moment, and the measure requires approximately 6 minutes to complete. Summary statistics are presented for participants (n) without intercurrent events.
Time frame: Baseline and Week 52
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52 | -7.1 Scores on a scale | Standard Deviation 4.77 |
| Secukinumab, No Load, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52 | -7.6 Scores on a scale | Standard Deviation 5.38 |
| Placebo, Core Phase | Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52 | -6.4 Scores on a scale | Standard Deviation 4.64 |
p-value: 0.0012Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating no problem and 10 indicating worst problem), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity.
Time frame: Baseline and Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -2.35 scores on a scale | Standard Error 0.201 |
| Secukinumab, No Load, Core Phase | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -2.43 scores on a scale | Standard Error 0.203 |
| Placebo, Core Phase | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -1.46 scores on a scale | Standard Error 0.205 |
Comparison: week 16p-value: 0.000695% CI: [-1.39, -0.38]mixed model repeated measures (MMRM)
Comparison: week 16p-value: 0.000295% CI: [-1.47, -0.47]mixed model repeated measures (MMRM)
Secondary
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity.
Time frame: Baseline and Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | -1.75 Index | Standard Error 0.202 |
| Secukinumab, No Load, Core Phase | Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | -1.64 Index | Standard Error 0.204 |
| Placebo, Core Phase | Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | -1.01 Index | Standard Error 0.206 |
Comparison: week 16p-value: 0.004195% CI: [-1.26, -0.24]MMRM
Comparison: week 16p-value: 0.014395% CI: [-1.15, -0.13]MMRM
Secondary
Change in High Sensitivity C-reactive Protein
High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.
Time frame: Baseline and Week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in High Sensitivity C-reactive Protein | 0.64 ratio | Standard Error 1.078 |
| Secukinumab, No Load, Core Phase | Change in High Sensitivity C-reactive Protein | 0.64 ratio | Standard Error 1.079 |
| Placebo, Core Phase | Change in High Sensitivity C-reactive Protein | 0.91 ratio | Standard Error 1.08 |
Comparison: week 16p-value: 0.000295% CI: [0.58, 0.84]MMRM
Comparison: week 16p-value: 0.000295% CI: [0.58, 0.84]MMRM
Secondary
Change in Sacroiliac Joint Edema - Week 16
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
Time frame: Baseline and Week 16
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Sacroiliac Joint Edema - Week 16 | -1.68 Scores on a Scale | Standard Error 0.24 |
| Secukinumab, No Load, Core Phase | Change in Sacroiliac Joint Edema - Week 16 | -1.03 Scores on a Scale | Standard Error 0.18 |
| Placebo, Core Phase | Change in Sacroiliac Joint Edema - Week 16 | -0.39 Scores on a Scale | Standard Error 0.15 |
Comparison: week 16p-value: <0.0001ANCOVA
Comparison: week 16p-value: <0.0001ANCOVA
Secondary
Change in Sacroiliac Joint Edema - Week 52
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
Time frame: Baseline and Week 52
Population: Full Analysis Set where intercurrent event = no.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Sacroiliac Joint Edema - Week 52 | -2.9 Scores on a scale | Standard Deviation 4.54 |
| Secukinumab, No Load, Core Phase | Change in Sacroiliac Joint Edema - Week 52 | -1.9 Scores on a scale | Standard Deviation 3.4 |
| Placebo, Core Phase | Change in Sacroiliac Joint Edema - Week 52 | -0.1 Scores on a scale | Standard Deviation 1.97 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.
Time frame: Baseline and Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab, Load, Core Phase | Change in Short Form-36 Physical Component Summary (SF-36 PCS) | 5.71 Scores on a Scale | Standard Error 0.683 |
| Secukinumab, No Load, Core Phase | Change in Short Form-36 Physical Component Summary (SF-36 PCS) | 5.57 Scores on a Scale | Standard Error 0.694 |
| Placebo, Core Phase | Change in Short Form-36 Physical Component Summary (SF-36 PCS) | 2.93 Scores on a Scale | Standard Error 0.705 |
Comparison: week 16p-value: 0.000695% CI: [1.2, 4.34]ANCOVA
Comparison: week 16p-value: 0.001195% CI: [1.06, 4.22]ANCOVA
Secondary
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.
Time frame: Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response | 105 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response | 107 Participants |
| Placebo, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response | 85 Participants |
Comparison: week 16p-value: 0.02695% CI: [1.06, 2.43]Regression, Logistic
Comparison: week 16p-value: 0.014995% CI: [1.11, 2.54]Regression, Logistic
Secondary
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
Time frame: Week 16 and week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 16 | 74 Participants |
| Secukinumab, Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 52 | 62 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 16 | 75 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 52 | 70 Participants |
| Placebo, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 16 | 52 Participants |
| Placebo, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response | week 52 | 36 Participants |
Comparison: week 16p-value: 0.010895% CI: [1.14, 2.74]Regression, Logistic
Comparison: week 16p-value: 0.008795% CI: [1.16, 2.78]Regression, Logistic
p-value: 0.001695% CI: [1.34, 3.49]Regression, Linear
p-value: <0.000195% CI: [1.62, 4.19]Regression, Linear
Secondary
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.
Time frame: Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response | 74 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response | 66 Participants |
| Placebo, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response | 44 Participants |
Comparison: week 16p-value: 0.000595% CI: [1.43, 3.58]Regression, Logistic
Comparison: week 16p-value: 0.009495% CI: [1.16, 2.94]Regression, Logistic
Secondary
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.
Time frame: Week 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR) | 40 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR) | 39 Participants |
| Placebo, Core Phase | The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR) | 13 Participants |
Comparison: week 16p-value: <0.000195% CI: [1.95, 7.39]Regression, Logistic
Comparison: week 16p-value: 0.000195% CI: [1.87, 7.1]Regression, Logistic
Secondary
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity.
Time frame: Week 16 and 52
Population: Full Analysis set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 16 | 69 Participants |
| Secukinumab, Load, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 52 | 57 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 16 | 69 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 52 | 65 Participants |
| Placebo, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 16 | 39 Participants |
| Placebo, Core Phase | The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | week 52 | 37 Participants |
Comparison: week 16p-value: 0.000195% CI: [1.58, 4.07]Regression, Logistic
Comparison: week 16p-value: 0.000295% CI: [1.51, 3.89]Regression, Logistic
Comparison: week 52p-value: 0.005695% CI: [1.22, 3.24]Regression, Logistic
Comparison: week 52p-value: 0.000595% CI: [1.45, 3.78]Regression, Logistic
Secondary
The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease
Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)
Time frame: Week 52
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab, Load, Core Phase | The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease | 29 Participants |
| Secukinumab, No Load, Core Phase | The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease | 44 Participants |
| Placebo, Core Phase | The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease | 19 Participants |
Comparison: week 52p-value: 0.057795% CI: [0.98, 3.45]Regression, Logistic
Comparison: week 52p-value: 0.000395% CI: [1.65, 5.41]Regression, Logistic