16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Key facts

Study ID

NCT01358175

Run by

Novartis Pharmaceuticals

People needed

371

Starts

2011-10-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-09

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 at least 18 years of age
• 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 are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
• Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

You may not qualify if…

• Chest X-ray 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Cedar Rapids, Iowa, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Kingsport, Tennessee, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Benbrook, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Spokane, Washington, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Genk, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Burgas, Bulgaria, Bulgaria
• Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
• Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria, Bulgaria
• Novartis Investigative Site — Winnipeg, Manitoba, Canada
• Novartis Investigative Site — St. John's, Newfoundland and Labrador, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Limoges, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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