Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Condition: Non-radiographic Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Secukinumab; Placebo
Intervention description: Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly; Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 555.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-radiographic spondyloarthritis; axial spondyloarthritis; Ankylosing Spondylitis

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
    

Eligibility criteria:

        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