5391W-13: Mease Lilly I1F-MC-RHAP

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

Type of Study
Rheumatology - Psoriatic Arthritis
Short Description

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.


Status
Open
Principal Investigator
Philip J. Mease, MD
Eligibility Notes

Inclusion Criteria:

  • Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active psoriatic arthritis (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

Exclusion Criteria:

  • Current or prior use of biologic agents for treatment of Ps or PsA
  • Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
  • Current use of more than one conventional DMARD
  • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
  • Serious disorder or illness other than psoriatic arthritis
  • Serious infection within the last 3 months
  • Breastfeeding or nursing (lactating) women
Start Date
5/17/2013
Contact Name
Sephren Barrow
Phone
206-386-6248
Alternate Phone
206-386-3201
Email
Sephren.Barrow@swedish.org
Alternate Email
Allison.Everett@swedish.org