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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anklyosing Spondylitis

In brief

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

Key facts

Study ID

NCT01649375

Run by

Novartis Pharmaceuticals

People needed

219

Starts

2012-10-18

Expected to finish

2018-09-18

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Edina, Minnesota, United States
• Novartis Investigative Site — Tupelo, Mississippi, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Winnipeg, Manitoba, Canada
• Novartis Investigative Site — Pointe-Claire, Quebec, Canada
• Novartis Investigative Site — Québec, Quebec, Canada
• Novartis Investigative Site — Sainte-Foy, Quebec, Canada
• Novartis Investigative Site — Bruntál, Czech Republic, Czechia
• Novartis Investigative Site — Ostrava, Czech Republic, Czechia
• Novartis Investigative Site — Prague, Czech Republic, Czechia
• Novartis Investigative Site — Uherské Hradiště, Czechia
• Novartis Investigative Site — HUS, Finland, Finland
• Novartis Investigative Site — Helsinki, Finland
• Novartis Investigative Site — Hyvinkää, Finland
• Novartis Investigative Site — Jyväskylä, Finland
• Novartis Investigative Site — Seinäjoki, Finland
• Novartis Investigative Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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