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A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

NCT03671148

CompletedPhase 3

Sponsor: AbbVie

Conditions: Psoriatic Arthritis (PsA)

Interventions: Placebo, Risankizumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
* Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
* Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

* Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
* Participant has a known hypersensitivity to risankizumab.
Locations (138)
  • Anniston, Alabama, United States
  • Fullerton, California, United States
  • Huntington Beach, California, United States
  • La Palma, California, United States
  • San Leandro, California, United States
  • Upland, California, United States
  • Denver, Colorado, United States
  • Bridgeport, Connecticut, United States
  • New Haven, Connecticut, United States
  • Aventura, Florida, United States
  • Gainesville, Florida, United States
  • Hialeah, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Palm Harbor, Florida, United States
  • Plantation, Florida, United States
  • St. Petersburg, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Skokie, Illinois, United States
  • Springfield, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • Monroe, Louisiana, United States
  • Portland, Maine, United States
  • Hagerstown, Maryland, United States
  • Wheaton, Maryland, United States
  • Worcester, Massachusetts, United States
  • + 108 more on CT.gov