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ClinicalTrial.gov Identifier : NCT02782663

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease 

    Status Active, not recruiting
    Related Conditions
    Crohn's Disease (CD)

Enrollment Details

107 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Protocol ID
M14-327

Brief summary

Top

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494). 

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 75 Years

Canada: 5

0
Edmonton, AB
1
Vancouver, BC
2
Vancouver, BC
3
Vaughan, ON
4
Montreal, 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

    Non-Randomized

  • 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

    Open Label

  • 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

    • Participant must have completed Study M13-740 through Week 52.
    • If female, participant must be postmenopausal, surgically sterile or using a birth control method.
    • For any reason participant is considered by the investigator to be an unsuitable candidate
    • Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
    • Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740