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SELECT-EARLY

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

    Status Recruiting
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

1002 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M13-545

Brief summary

Top

This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX) monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis

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

Canada: 5

0
Edmonton, AB
1
Winnipeg, MB
2
Winnipeg, MB
3
Thornhill, ON
4
Rimouski, 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.
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    Allocation

    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.
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    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.
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    Intervention 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 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.
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    Purpose

    Treatment

    • Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.
    • Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
    • Subjects with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
    • Subject 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.
    • Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening.
    • Intolerant to Methotrexate (MTX).
    • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
    • Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
    • History of inflammatory joint disease other than Rheumatoid Arthritis (RA). History of secondary Sjogren's Syndrome is permitted.

More on this trial

Clinical Trials.gov