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ClinicalTrial.gov Identifier : NCT00573794

Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

    Status Active, not recruiting
    Related Conditions

Enrollment Details

800 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M10-223

Brief summary

Top

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis.

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

Canada: 13

0
Calgary, AB
1
Edmonton, AB
2
Hamilton, ON
3
Kelowna, BC
4
Montreal, QC
5
Montreal, QC
6
Quebec, QC
7
Greater Sudbury, ON
8
Toronto, ON
9
Vancouver, BC
10
Vaughan, ON
11
Victoria, BC
12
Winnipeg, MB
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Study Design

  • 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 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

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
    ?

    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.
    ?

    Purpose

    Treatment

    • Subject must have successfully enrolled and completed either the M06-826 study or the M06-827 study
    • Subject is judged to be in generally good health as determined by the principal investigator
    • Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
    • Subject considered by the investigator, for any reason, to be an unsuitable candidate
    • Female subject who is pregnant or breast-feeding or considering becoming pregnant

More on this trial

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