Last updated on December 2018

A Randomized Double-blind Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ankylosing spondylitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 TNF 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 TNF inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization
  • Patients who have been on a TNF 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-TNF 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 TNF
  • Patients who have taken more than two anti-TNF 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

Other protocol-defined inclusion/exclusion criteria may apply.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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