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ClinicalTrial.gov Identifier : NCT01960855

A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy.

    Status Study is now Completed Canada site Cancelled
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

276 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Protocol ID
M13-550

Brief summary

Top

This is a multi center, randomized, double-blind, placebo-controlled phase 2 study in subjects with moderately to severely active rheumatoid arthritis on background methotrexate who have failed anti-Tumor Necrosis Factor (TNF) biologic therapy.

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

Canada: 3

0
Burlington, ON
1
Toronto, ON
2
Toronto, ON
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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

    • Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
    • Subjects must have been receiving oral or parenteral MTX therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study.
    • Subjects have been treated with 1 or more anti-TNF biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
    • Have active RA as defined by the following minimum disease activity criteria:
      • >= 6 swollen joints (based on 66 joint counts) at Screening and Baseline, >= 6 tender joints (based on 68 joint counts) at Screening and Baseline, hs-CRP > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-CCP antibody.
    • Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
    • Pregnant or breastfeeding female
    • Ongoing or active infection.

More on this trial

Clinical Trials.gov