Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab (AIN457) 150 mg s.c.; Secukinumab (AIN457) 150 mg s.c.; Placebo - Secukinumab (AIN457) 150 mg s.c.
Intervention description: Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 4 x 150 mg secukinumab s.c. every 4 weeks Delayed NSAID tapering (tapering following 4 weeks of secukinumab treatment).; Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 3 x 150 mg secukinumab s.c. every 4 weeks Early NSAID tapering (tapering at the start of secukinumab treatment).; Placebo for 15 weeks. From Week 16 on, 5 x 150 mg secukinumab s.c. weekly.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; NSAID; ASAS; ASAS-NSAID score; Secukinumab

Summary:

      This study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS)
      20 response to secukinumab and evaluated to which extent concomitant nonsteroidal
      anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab
      or placebo following an initial run-in phase of stable NSAID therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of active AS with prior documented radiologic evidence fulfilling the
             Modified New York criteria for AS

          -  Active AS assessed by total BASDAI ≥ 4 (0-10) at baseline

          -  Spinal pain as measured by BASDAI Question 2 ≥ 4 cm on a 0-10 cm numeric rating scale
             at baseline

          -  Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline

          -  Patients should have been on at least 2 different NSAIDs at the highest recommended
             dose for at least 4 weeks prior to randomization, with an inadequate response or
             failure to respond, or less if therapy had to be reduced due to intolerance, toxicity
             or contraindications

          -  Patients must report regular intake of NSAIDs of at least 50% of the highest
             recommended dose at Screening.

          -  Patients with prior TNFα inhibitor therapy must report regular intake of NSAIDs of at
             least 50% of the highest recommended dose at baseline after the appropriate washout

          -  Patients are required to be on a stable dose of NSAIDs for at least 2 weeks before
             randomization

          -  Patients who have previously been on a TNFα inhibitor will be allowed entry into study
             after an appropriate wash-out period prior to randomization

          -  Patients who have been on a TNFα inhibitor (not more than two) 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.

          -  Patients taking MTX or sulfasalazine are allowed to continue their medication and must
             have taken it for at least 3 months and be on a stable dose for at least 4 weeks prior
             to randomization

        Key Exclusion Criteria:

          -  Chest X-ray or MRI with evidence of ongoing infectious or malignant process.

          -  Previous exposure to Secukinumab or any other biologic drug directly targeting IL-17
             or IL-17 receptor

          -  Patients previously treated with any biological immunomodulating agents, except those
             targeting TNFα

          -  Patients who have taken more than two anti-TNFα agents

          -  Pregnant or nursing (lactating) women.

          -  History of ongoing, chronic or recurrent infectious disease or evidence of
             tuberculosis infection.

          -  Patients who are intolerant to NSAIDs