Axial Spondyloarthritis MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of axial spondylarthritis (AxSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS AxSpA classification criteria. - Patients with back pain for at least 3 months and age of onset less than 45 years. - Active AxSpA as assessed by total BASDAI score of at least 4 at Baseline. - Spinal pain numeric rating scale score of more than 4 at Baseline. - Inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 334 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: - Chest X-ray or MRI with evidence of ongoing infectious or malignant process. - Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha. - Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent. - Active ongoing inflammatory diseases other than axial spondyloarthritis. - Other ongoing mechanical diseases affecting the spine. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients with a spinal pain NRS score below 4;Timepoint(s) of evaluation of this end point: Week 8;Secondary Objective: To assess the superiority of secukinumab 150 mg compared to placebo in achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score < 4 at Week 8.;Main Objective: To assess the superiority of secukinumab 150 mg compared to placebo in achieving a spinal pain score < 4 on a 0-10 numerical rating score (NRS) at Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with a Bath ankylosing spondylitis disease activity index score below 4;Timepoint(s) of evaluation of this end point: Week 8 | — |
Countries
Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Finland, Germany, Greece, Ireland, Israel, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactIrena Feldmane
Novartis Pharma Services
Outcome results
None listed