Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

Keywords

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Ixekizumab Antirheumatic Agents Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W

Eligibility

You can join if…

Open to people ages 18 years and up

  • Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
  • Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
  • Men must agree to use a reliable method of birth control or remain abstinent during the study
  • Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
  • Have been treated with 1 or more conventional disease-modifying antirheumatic drugs(cDMARDs)

You CAN'T join if...

  • Current use of biologic agents for treatment of Ps or PsA
  • Inadequate response to greater than 2 biologic DMARDs
  • Current use of more than one cDMARDs
  • Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
  • Serious disorder or illness other than psoriatic arthritis
  • Serious infection within the last 3 months
  • Breastfeeding or nursing (lactating) women

Locations

  • University of California - San Diego
    La Jolla California 92093 United States
  • Purushotham & Akther Kotha MD Inc
    La Mesa California 91942 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
ID
NCT02349295
Phase
Phase 3
Study Type
Interventional
Last Updated