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ClinicalTrial.gov Identifier : NCT03671148

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

    Status Recruiting
    Related Conditions
    Psoriatic Arthritis

Enrollment Details

420 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M15-998

Brief summary

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

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 5

0
Victoria, BC
1
Winnipeg, MB
2
Hamilton, ON
3
Waterloo, ON
4
Rimouski, QC
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Study Design

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Observational Model

    Parallel assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double (Participant/Investigator)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Clinical diagnosis of 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.
    • Subject has active disease at Baseline.
    • Diagnosis of active plaque psoriasis.
    • Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
    • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
    • Subject has a known hypersensitivity to risankizumab.

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