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ClinicalTrial.gov Identifier : NCT01848561

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC).

    Status Recruiting
    Related Conditions
    Ulcerative Colitis

Enrollment Details

8250 Worldwide Enrollment Goal

Phases: 

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

This is a type IV phase trial.

Protocol ID
P11-282

Brief summary

Top

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

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

Canada: 21

0
Edmonton, AB
1
Edmonton, AB
2
Fredericton, NB
3
Guelph, ON
4
Halifax, NS
5
Montreal, QC
6
Ottawa, ON
7
Saskatoon, SK
8
Surrey, BC
9
Toronto, ON
10
Vancouver, BC
11
New Westminster, BC
12
Vancouver, BC
13
Victoria, BC
14
Brampton, ON
15
Hamilton, ON
16
London, ON
17
Oshawa, ON
18
Ottawa, ON
19
Montréal, QC
20
Sherbrooke, QC
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Study Design

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

    Cohort

  • The relationship between the observation period and the time of patient enrollment. Time perspective can be prospective: looking forward using periodic observations usually collected following patient enrollment, or retrospective: looking back using observations usually collected prior to patient selection and enrollment.
    ?

    Time Perspective

    Prospective

    • For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:
      • Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR
      • Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy
    • For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
    • Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol
    • Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
    • Patients who are being treated with any investigational agents and/or approved biologics other than Humira.

More on this trial

Clinical Trials.gov