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

Status:	Completed
Conditions:	Arthritis, Neurology
Therapuetic Areas:	Neurology, Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/6/2019
Start Date:	October 18, 2012
End Date:	September 18, 2018

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

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

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 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

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

- Other protocol-defined inclusion/exclusion criteria may apply.

We found this trial at

sites

Novartis Investigative Site

Edina, Minnesota 55435

from

Edina, MN