5554W-14: Mease Novartis CAIN457F2314

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Type of Study
Rheumatology - Ankylosing Spondylitis
Short Description

The purpose of this study is to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.


Status
Open
Principal Investigator
Philip J. Mease, MD
Eligibility Notes

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.

Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy. -- Other protocol-defined inclusion/exclusion criteria do apply.

Start Date
4/21/2014
Contact Name
Jodie Davila, RN
Phone
206-386-6252
Alternate Phone
206-386-6248
Email
Jodie.Davila@swedish.org
Alternate Email
Sephren.Barrow@swedish.org