CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 211 enrolled
Drug / intervention
Secukinumab (AIN457) 150 mg s.c. +2 moredrug
Likely dose
Secukinumab (AIN457) 150 mg s.c.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02763046
NCT02763046Phase 4Completed
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A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)

Novartis Pharmaceuticals·interventional·Posted May 5, 2016·Updated Oct 8, 2021

In Brief

A Phase 4 clinical trial evaluating Secukinumab (AIN457) 150 mg s.c. and Placebo - Secukinumab (AIN457) 150 mg s.c. for Ankylosing Spondylitis. Completed, enrolled 211 participants across 39 sites.

Detailed Summary

This study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to secukinumab and evaluated to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab or placebo following an initial run-in phase of stable NSAID therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 5, 2016
Enrollment StartMay 31, 2016
Primary CompletionSep 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago

Interventions

Secukinumab (AIN457) 150 mg s.c.drug

Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 4 x 150 mg secukinumab s.c. every 4 weeks Delayed NSAID tapering (tapering following 4 weeks of secukinumab treatment).

Secukinumab (AIN457) 150 mg s.c.drug

Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 3 x 150 mg secukinumab s.c. every 4 weeks Early NSAID tapering (tapering at the start of secukinumab treatment).

Placebo - Secukinumab (AIN457) 150 mg s.c.drug

Placebo for 15 weeks. From Week 16 on, 5 x 150 mg secukinumab s.c. weekly.