Ankylosing Spondylitis
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Male or non-pregnant, non-nursing female patients at least 18 years of age *Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy *Active AS assessed by total BASDAI >= 4 on a scale of 0-10 *Spinal pain as measured by BASDAI question #2 >= 4 (0-10) *Total back pain as measured by visual analog scale (VAS) >= 40 mm (0-100 mm) *hsCRP >= 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray
Exclusion criteria
Exclusion criteria: *Patients with total ankylosis of the spine *Pregnant or nursing (lactating) women *Evidence of ongoing infectious or malignant process *Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNF-alpha *Subjects taking high potency opioid analgesics *Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ] To demonstrate the proportion of subjects on secukinumab (combined 150 mg s.c. and 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ] To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.) efficacy Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ] To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104 efficacy No new syndesmophytes as measured by mSASSS [ Time Frame: 104 weeks ] The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS efficacy Assessment of SpondyloArthritis International Society 20 (ASAS20) [ Time Frame: 104 weeks ] ASAS20 response is defined as an improvement of >=20% and >=1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of >=20% and >=1 unit in the remaining domain efficacy ASAS40 [ Time Frame: 104 weeks ] 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 efficacy ASAS partial remission [ Time Frame: 104 weeks ] ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10 efficacy Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: 104 weeks ] An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CR | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma K. K.
Outcome results
None listed