Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Treatments secukinumab (75 mg), secukinumab (150 mg), placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date October 2011
End date February 2015
Trial size 372 participants
Trial identifier NCT01358175, 2010-024529-18, CAIN457F2305

Summary

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
secukinumab (75 mg)
Secukinumab (75 mg)
(Experimental)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
secukinumab (150 mg)
Secukinumab (150 mg)
(Placebo Comparator)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
placebo
Placebo

Primary Outcomes

Measure
Assessment of SpondyloArthritis International Society / ASAS 20 response
time frame: 16 weeks

Secondary Outcomes

Measure
ASAS 40 response
time frame: 16 weeks
Serum hsCRP
time frame: Week 16
ASAS 5/6 response
time frame: 16 weeks
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
time frame: 16 weeks
Physical function component of the short-form health survey / SF-36 PCS
time frame: 16 weeks
Ankylosing Spondylitis Quality of Life questionnaire / ASQoL
time frame: 16 weeks
ASAS partial remission
time frame: 16 weeks
Overall safety and tolerability
time frame: 104 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Male or non-pregnant, non-lactating female patients at least 18 years of age - Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) - Patients should have been on NSAIDs with an inadequate response - Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose - Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion criteria: - Chest X-ray with evidence of ongoing infectious or malignant process - Patients with total ankylosis of the spine - Patients previously treated with any biological immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies - Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Novartis.