Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Placebo
Intervention description: Induction: 4x 150 mg Secukinumab s.c. weekly
Maintenance: 150 mg Secukinumab s.c. monthly
All Subjects received blinded treatment weekly starting at baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until Week 16. At Week 16, Group 1 patients continued using secukinumab 150 mg and Group 2 patients started receiving secukinumab 150 mg dosing every four weeks. Treatment was provided open-label from Week 16 onward, as all patients took 150 mg s.c. every 4 weeks; however, subjects, investigators, and site staff remained blinded to initial randomized group assignment.; 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 458.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondyloarthritis; Axial spondyloarthritis

Summary:

      The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to
      demonstrate safety and tolerability of secukinumab compared to placebo in patients with
      ankylosing spondylitis at week 16 and long term safety up to Week 52.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or non-pregnant, non-lactating female patients at least 18 years of age

        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:

          -  Active AS assessed by BASDAI ≥4 (0-10) at Baseline

          -  Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline

          -  Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline Patients should have
             had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose
             for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to
             randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance,
             toxicity or contraindications Patients who are regularly taking NSAIDs (including
             COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable
             dose for at least 2 weeks before randomisation Patients who have been on a TNFα
             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
             randomization or have been intolerant to at least one administration of an anti-TNFα
             agent

        Exclusion Criteria:

          -  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
                  IL-17 or IL-17 receptor

               -  Pregnant or nursing (lactating) women