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A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

    Status Recruiting
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

1629 Worldwide Enrollment Goal

Study Type:  Interventional

This is a type  phase trial.

Protocol ID

Brief summary


This is a phase 3, randomized, double-blind study comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a stable background of Methotrexate (MTX) and who have an inadequate response to MTX. 

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

Canada: 6

Winnipeg, MB
Winnipeg, MB
St. John's, NL
Hamilton, ON
Thornhill, ON
Sainte-Foy, QC
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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 RA for greater than or equal to 3 months.
    • Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for greater than or equal to 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
    • 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.
    • At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
    • Subjects with prior exposure to only one Biological disease-modifying anti-rheumatic drugs (bDMARD) (except ADA) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
    • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
    • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). 
    • Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator. 
    • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

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