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ClinicalTrial.gov Identifier : NCT00524537

A Long-Term Registry of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD).

    Status Completed
    Related Conditions

Enrollment Details

5067 Worldwide Enrollment Goal

Phases: 

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

This is a type IV phase trial.

Protocol ID
P06-134

Brief summary

Top

The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.

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

Canada: 32

0
Abbotsford, BC
1
Calgary, AB
2
Guelph, ON
3
Halifax, NS
4
Hamilton, ON
5
Kelowna, BC
6
Levis, QC
7
London, ON
8
Longueuil, QC
9
Montreal, QC
10
Montreal,
11
Saint-Charles-Borromée,
12
Saskatoon,
13
Saskatoon,
14
Toronto,
15
Saint John,
16
St. John's,
17
Toronto,
18
Toronto,
19
Truro,
20
Vancouver,
21
Vancouver, BC
22
Victoria, BC
23
Barrie, ON
24
Hamilton, ON
25
Montreal, QC
26
Montreal, QC
27
Ottawa, ON
28
Quebec, QC
29
Saskatoon, SK
30
Victoria, BC
31
Winnipeg, MB
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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.
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    Time Perspective

    Prospective

    • Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in AbbVie sponsored investigational CD trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
    • Subjects who were participants in AbbVie sponsored investigational Crohn's disease trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
    • Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
    • Subjects willing to consent to data being collected and provided to AbbVie.
    • Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.
    • Subjects should not be enrolled if they cannot be treated in accordance with the local product label.

More on this trial

Clinical Trials.gov