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You are here Identifier : NCT02065570

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

    Status Recruiting
    Related Conditions
    Crohn's Disease

Enrollment Details

514 Worldwide Enrollment Goal


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

This is a type III phase trial.

Protocol ID

Brief summary


This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

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

Canada: 8

Calgary, AB
Edmonton, AB
Halifax, NS
Montréal, QC
Winnipeg, MB
London, ON
Sudbury, ON
Vaughan, 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.



  • 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.



    • Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
    • Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
    • Mucosal ulceration on endoscopy.
    • Subject with ulcerative colitis or indeterminate colitis.
    • Subject who has had surgical bowel resections in the past 6 months or is planning resection.
    • Subjects with an ostomy or ileoanal pouch.
    • Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
    • Subject who has short bowel syndrome.
    • Chronic recurring infections or active Tuberculosis (TB).

More on this trial