NCT02896127 - Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis | Biotech Hunter

Enrollment

458

Participants

Timeline

Start Date

October 18, 2016

Primary Completion Date

May 14, 2018

Study Completion Date

March 19, 2019

Conditions

Ankylosing Spondyloarthritis

Interventions

DRUG

Secukinumab

"Induction: 4x 150 mg Secukinumab s.c. weekly~Maintenance: 150 mg Secukinumab s.c. monthly~All Subjects received blinded treatment weekly starting at baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until Week 16. At Week 16, Group 1 patients continued using secukinumab 150 mg and Group 2 patients started receiving secukinumab 150 mg dosing every four weeks. Treatment was provided open-label from Week 16 onward, as all patients took 150 mg s.c. every 4 weeks; however, subjects, investigators, and site staff remained blinded to initial randomized group assignment."

DRUG

Placebo

Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Trial Locations (44)

51000

Novartis Investigative Site, Guangzhou

61469

Novartis Investigative Site, Gwangju

100029

Novartis Investigative Site, Beijing

100039

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

200040

Novartis Investigative Site, Shanghai

200127

Novartis Investigative Site, Shanghai

200433

Novartis Investigative Site, Shanghai

210029

Novartis Investigative Site, Nanjing

230001

Novartis Investigative Site, Hefei

230022

Novartis Investigative Site, Hefei

233004

Novartis Investigative Site, Bengbu

300052

Novartis Investigative Site, Tianjin

361001

Novartis Investigative Site, Xiamen

410008

Novartis Investigative Site, Changsha

410011

Novartis Investigative Site, Changsha

430030

Novartis Investigative Site, Wuhan

510000

Novartis Investigative Site, Guangzhou

602739

Novartis Investigative Site, Busan

610041

Novartis Investigative Site, Chengdu

830001

Novartis Investigative Site, Ürümqi

030001

Novartis Investigative Site, Taiyuan

Unknown

Novartis Investigative Site, Shanghai

Novartis Investigative Site, Shanxi Province

Novartis Investigative Site, Zhejiang

Novartis Investigative Site, Zhenjiang

792 01

Novartis Investigative Site, Bruntál

772 00

Novartis Investigative Site, Ostrava

128 50

Novartis Investigative Site, Prague

148 00

Novartis Investigative Site, Prague

686 01

Novartis Investigative Site, Uherské Hradiště

06591

Novartis Investigative Site, Seoul

405 760

Novartis Investigative Site, Incheon

03080

Novartis Investigative Site, Seoul

04763

Novartis Investigative Site, Seoul

RG1 5AN

Novartis Investigative Site, Reading

BD9 6RJ

Novartis Investigative Site, Bradford

BA1 1RL

Novartis Investigative Site, Bath

DN2 5LT

Novartis Investigative Site, Doncaster

HU16 5JQ

Novartis Investigative Site, Hull

NW1

Novartis Investigative Site, London

NR1 3SR

Novartis Investigative Site, Norwich

SO16 6YD

Novartis Investigative Site, Southampton

WN6 9EP

Novartis Investigative Site, Wigan