CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Secukinumab (75 mg) +2 moredrug
Likely dose
Secukinumab (75 mg)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/NCT01649375
NCT01649375Phase 3Completed

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

Novartis Pharmaceuticals·interventional·Posted Jul 25, 2012·Updated Oct 30, 2019

In Brief

A Phase 3 clinical trial evaluating Secukinumab (75 mg), Placebo, and 1 other intervention for Anklyosing Spondylitis. Completed, enrolled 219 participants across 53 sites in 13 countries.

Detailed Summary

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Czechia, Finland, Germany, Italy, Netherlands, Russia, Singapore, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2012
Enrollment StartOct 18, 2012
Primary CompletionAug 4, 2014
Study CompletionSep 18, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

Secukinumab (75 mg)drug

Secukinumab 75 mg s.c.

Placebodrug

Placebo

Secukinumab (150 mg)drug

Secukinumab 150 mg s.c.