Spondylitis, Ankylosing
Conditions
Keywords
AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection
Brief summary
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as core study, as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.
Interventions
BIOLOGICALSecukinumab
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
OTHERPlacebo (Pbo)
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
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
patients having completed the core study CAIN457F2305, indication for treatment extension. --
Exclusion criteria
history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the core study CAIN457F2305.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 104 to Week 260 | ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 104 to Week 260 | ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group |
Countries
Belgium, Bulgaria, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Russia, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
CAIN457F2305 core study consisted of a screening period of 4 Wks before randomization followed by a treatment period of 2 years (Wk 0 through Wk 104). At Wk 104, patients continued into the extension on the same dose of AIN457. If they were on Placebo in the core then randomized to either Group 1 or 2.
Pre-assignment details
Group 1: AIN457 75mg plus placebo 150mg dosed every 4 weeks from Wk 104E1 to Wk 152. At Wk 156 (after unblinding), only AIN457 75mg was dosed or up titrated to AIN457 150mg. Group 2: AIN457 150mg plus placebo 75mg dosed every 4 weeks from Wk 104E1 through Wk 152. At Wk 156 (after unblinding), only secukinumab 150 mg was dosed.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab (AIN457) 75mg Group 1 AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group. | 100 |
| Secukinumab (AIN457) 150mg Group 2 AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W. | 87 |
| Pbo in Core Then AIN457 75mg Group 1 Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group. | 46 |
| Pbo in Core Then AIN457 150mg Group 2 Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W. | 41 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 3 | 3 |
| Overall Study | Death | 1 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 |
| Overall Study | Subject/guardian decision | 6 | 9 | 3 | 1 |
| Overall Study | Technical problems | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Secukinumab (AIN457) 75mg Group 1 | Total | Pbo in Core Then AIN457 150mg Group 2 | Pbo in Core Then AIN457 75mg Group 1 | Secukinumab (AIN457) 150mg Group 2 |
|---|---|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 13.37 | 41.2 years STANDARD_DEVIATION 12.68 | 42.5 years STANDARD_DEVIATION 12.13 | 43.0 years STANDARD_DEVIATION 13 | 38.2 years STANDARD_DEVIATION 11.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 12 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 50 Participants | 8 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 45 Participants | 4 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) White | 61 Participants | 167 Participants | 28 Participants | 30 Participants | 48 Participants |
| Sex: Female, Male Female | 25 Participants | 76 Participants | 12 Participants | 10 Participants | 29 Participants |
| Sex: Female, Male Male | 75 Participants | 198 Participants | 29 Participants | 36 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 179 | 1 / 263 | 1 / 122 |
| other Total, other adverse events | 126 / 179 | 157 / 263 | 45 / 122 |
| serious Total, serious adverse events | 36 / 179 | 33 / 263 | 5 / 122 |
Outcome results
Primary
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Time frame: Week 104 to Week 260
Population: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 104 | 71.4 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 116 | 76.0 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 128 | 70.1 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 140 | 77.1 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 156 | 75.5 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 168 | 74.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 180 | 81.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 192 | 72.3 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 208 | 73.4 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 220 | 74.4 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 232 | 76.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 244 | 74.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 260 | 71.3 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 140 | 75.0 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 260 | 77.6 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 232 | 82.1 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 192 | 84.8 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 128 | 77.1 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 104 | 80.0 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 220 | 81.8 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 208 | 79.7 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 168 | 78.3 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 156 | 80.2 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 116 | 82.1 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 244 | 82.1 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 180 | 80.0 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 232 | 75.7 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 140 | 75.6 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 156 | 76.1 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 260 | 81.6 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 168 | 83.3 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 180 | 81.0 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 244 | 80.0 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 192 | 81.0 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 208 | 75.0 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 220 | 81.1 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 104 | 78.6 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 116 | 76.1 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 128 | 84.8 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 220 | 75.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 192 | 73.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 140 | 72.5 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 104 | 73.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 180 | 78.4 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 168 | 78.4 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 128 | 75.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 116 | 70.7 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 156 | 67.5 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 208 | 78.4 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 260 | 80.6 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 244 | 76.5 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 | Week 232 | 77.8 % of responders |
Secondary
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group
Time frame: Week 104 to Week 260
Population: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 104 | 53.6 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 116 | 56.3 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 128 | 54.6 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 140 | 53.1 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 156 | 50.0 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 168 | 54.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 180 | 52.7 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 192 | 57.4 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 208 | 52.1 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 220 | 51.1 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 232 | 62.2 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 244 | 60.9 % of responders |
| Secukinumab (AIN457) 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 260 | 50.6 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 140 | 60.7 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 260 | 64.5 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 232 | 66.7 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 192 | 69.6 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 128 | 68.7 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 104 | 65.0 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 220 | 67.5 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 208 | 60.8 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 168 | 67.5 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 156 | 62.8 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 116 | 59.5 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 244 | 70.5 % of responders |
| Secukinumab (AIN457) 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 180 | 68.8 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 232 | 59.5 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 140 | 53.3 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 156 | 54.3 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 260 | 63.2 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 168 | 42.9 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 180 | 52.4 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 244 | 62.9 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 192 | 52.4 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 208 | 62.5 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 220 | 54.1 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 104 | 57.1 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 116 | 54.3 % of responders |
| Pbo in Core Then AIN457 75mg Group 1 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 128 | 58.7 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 220 | 63.9 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 192 | 62.2 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 140 | 60.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 104 | 48.6 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 180 | 67.6 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 168 | 62.2 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 128 | 55.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 116 | 51.2 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 156 | 55.0 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 208 | 56.8 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 260 | 66.7 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 244 | 61.8 % of responders |
| Pbo in Core Then AIN457 150mg Group 2 | Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 | Week 232 | 69.4 % of responders |