Ankylosing Spondylitis
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI >= 4 (0-10) and spinal pain as measured by VAS>= 4 cm (BASDAI question #2) at Baseline -Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications -Patients who have been on a TNFalpha inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFalpha agent
Exclusion criteria
Exclusion criteria: -Patients with total ankylosis of the spine -Patients previously treated with any biological immunomodulating agents except for those targeting TNFalpha -Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis -Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of SpondyloArthritis International Society criteria (ASAS) 20 response [ Time Frame: week 16 ] To assess the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS(Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS 40 response [ Time Frame: Week 16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response 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 Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 [ Time Frame: Week 16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP) hsCRP is measured as a marker of inflammation from blood samples during the study ASAS 5/6 response criteria [ Time Frame: Week 16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria The ASAS 5/6 improvement criteria is an improvement of >= 20% in at least five of all six domains BASDAI [ Time Frame: Baseline, week 16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI 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 Short Form Health Survey Physical Component Summary ( SF-36 PCS) [ Time Frame: Baseline, week16 ] The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component S | — |
Outcome results
None listed