16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

NCT01649375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2019-10-30

Study results available
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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

Conditions

  • Anklyosing Spondylitis

Interventions

DRUG

Secukinumab (75 mg)

Secukinumab 75 mg s.c.

DRUG

Placebo

Placebo

DRUG

Secukinumab (150 mg)

Secukinumab 150 mg s.c.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-18
Primary Completion
2014-08-04
Completion
2018-09-18
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Russia
  • Singapore
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01649375 on ClinicalTrials.gov