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24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

NCT01989468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2019-04-16

Study results available
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Summary

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Conditions

Interventions

BIOLOGICAL

Secukinumab

Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)

BIOLOGICAL

Placebo

Secukinumab placebo provided in 1 mL autoinjector

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
2014-04-10
Primary Completion
2015-05-27
Completion
2018-03-28

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • Puerto Rico
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01989468 on ClinicalTrials.gov