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A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

    Status Active, not recruiting
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

661 Worldwide Enrollment Goal


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

This is a type III phase trial.

Protocol ID

Brief summary


This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs who have had an inadequate response to csDMARDs.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 4

Winnipeg, MB
St. John's, NL
Sainte-Foy, QC
Saskatoon, SK
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.



  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.

    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.

    Intervention Model

    Parallel Assignment

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


    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

  • 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.



    • Adult male or female, at least 18 years old.
    • Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.
    • Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
    • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
    • Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.
    • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
    • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
    • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

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