16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2018-09-18
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Male or non-pregnant, non-lactating female patients

• Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984)

• Patients should have been on NSAIDs with an inadequate response

• Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose

• Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion Criteria:

• Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process

• Patients with total ankylosis of the spine

• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα

• Previous treatment with any cell-depleting therapies