NCT01863732|CompletedPhase 3ResultsDMCFDA Drug

Extension in AS: Sustainability of Benefits, Safety and Tolerability

MEASURE 1 ext

An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Novartis Pharmaceuticals ClinicalTrials.gov

Compare

2 other identifiers

CAIN457F2305E12013-001089-40

Study Type

interventional

Target

274

Locations

14 countries

Sites

Timeline

RegisteredMay 2013

StartedNov 2013

CompletionMar 2018

Brief Summary

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

274

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach

14 countries

56 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

May 23, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

November 6, 2013

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

July 30, 2019

Completed

Last Updated

July 30, 2019

Status Verified

June 1, 2019

Enrollment Period

4.4 years

First QC Date

May 23, 2013

Results QC Date

March 13, 2019

Last Update Submit

July 9, 2019

Conditions

Spondylitis, Ankylosing

Keywords

AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection

Outcome Measures

Primary Outcomes (1)

Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Week 104 to Week 260

Secondary Outcomes (1)

Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 104 to Week 260

Study Arms (6)

Secukinumab (AIN457) 75mg Grp1

EXPERIMENTAL

Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W