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Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

NCT02404350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 997

Last updated 2020-04-20

Study results available
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Summary

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Conditions

Interventions

BIOLOGICAL

Secukinumab

Anti IL-17a monoclonal antibody

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-16
Completion
2019-01-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Philippines
  • Russia
  • Spain
  • Sweden
  • Thailand
  • United Kingdom
  • Vietnam

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 NCT02404350 on ClinicalTrials.gov