Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-29 @ 1:43 PM
Study NCT ID:
NCT02750592
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2016-04-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: