You are about to leave an AbbVie Canada site, a Web site maintained by AbbVie Corporation.

This link is provided for your convenience only. AbbVie Corporation takes no responsibility for the content of any Web site maintained by any third party and makes no representation as to the accuracy or completeness of any information contained on this or any subsequent link.

Do you wish to leave this site?

Yes No

You are here

ClinicalTrial.gov Identifier : NCT02065622

Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis.

    Status Recruiting
    Related Conditions
    Ulcerative Colitis

Enrollment Details

969 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M14-033

Brief summary

Top

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in subjects with moderately to severely active Ulcerative Colitis.

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

Canada: 10

0
Calgary, AB
1
Edmonton, AB
2
Edmonton, AB
3
Victoria, BC
4
Winnipeg, MB
5
Halifax, NS
6
London, ON
7
Toronto, ON
8
Vaughan, ON
9
Montreal, QC
Would you like to know more about this trial?

Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    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.
    ?

    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.
    ?

    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.
    ?

    Purpose

    Treatment

    • Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
    • Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both.
    • Subject with Crohn's disease (CD) or indeterminate colitis (IC).
    • Current diagnosis of fulminant colitis and/or toxic megacolon.
    • Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
    • Chronic recurring infections or active Tuberculosis (TB).

More on this trial

Clinical Trials.gov