Overview

This trial is active, not recruiting.

Condition spondylitis, ankylosing
Treatments secukinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date November 2013
End date January 2018
Trial size 274 participants
Trial identifier NCT01863732, 2013-001089-40, CAIN457F2305E1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Secukinumab in PFS for s.c. self-administration Q4W
secukinumab AIN457
Eligible patients having completed the core study continue in the extension study under the same blinded dosage regimen (1 PFS); because of the double dummy design, placebo containing PFS is administered simultaneously, for a total of two injections. As of week 156, the same dosage regimen is administered open label, thus a single injection takes place.
(Experimental)
Secukinumab in PFS for s.c. self-administration Q4W
secukinumab AIN457
Eligible patients having completed the core study continue in the extension study under the same blinded dosage regimen (1 PFS); because of the double dummy design, placebo containing PFS is administered simultaneously, for a total of two injections. As of week 156, the same dosage regimen is administered open label, thus a single injection takes place.

Primary Outcomes

Measure
Assessment of Spondyloarthritis International Society criteria / ASAS 20 response
time frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305)

Secondary Outcomes

Measure
ASAS 40 response
time frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305)
Overall safety and tolerability
time frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Additional Information

Official title An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.