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Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

NCT02750592 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-09

Study results available
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Summary

The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.

Conditions

Interventions

DRUG

Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.

Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2017-07-05
Completion
2018-05-16

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02750592 on ClinicalTrials.gov