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

• Status: Completed
• Trial end date: 2019-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal

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