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Ucanada

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

    Status Recruiting
    Related Conditions
    Ulcerative Colitis

Enrollment Details

Phases: 

  • I
  • II
  • III
  • IV
Study Type:  Observational

This is a type IV phase trial.

Protocol ID
P15-325

Brief summary

Top

To evaluate the real-life effect of adalimumab on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients

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

Canada: 30

0
Fredericton, NB
1
Victoria, BC
2
New Westminster, BC
3
Montreal , QC
4
Lévis, QC
5
Saskatoon, SK
6
Québec, QC
7
Montreal , QC
8
Edmonton , AB
9
Vancouver, BC
10
Vancouver, BC
11
Saint John , NB
12
Brampton, ON
13
Calgary, AB
14
Chicoutimi, QC
15
Edmonton, AB
16
Hamilton, ON
17
Hamilton, ON
18
London, ON
19
Montréal, QC
20
Oshawa, ON
21
Ottawa, ON
22
Québec, QC
23
Sherbrooke, QC
24
Victoria,
25
Windsor, ON
26
Windsor, ON
27
Toronto, ON
28
Toronto, ON
29
Calgary, AB
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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

    • Patient must voluntarily sign and date a patient authorization.
    • Patient must be ≥ 18 years of age.
    • Patient must have confirmed diagnosis of UC.
    • Patient must have moderate to severe UC (a Mayo endoscopic sub score of 2 or 3).
    • Patient must have been previously treated with conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP), and who have had an inadequate response to or who are intolerant to such therapies.
    • Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
    • Patient has previously received adalimumab or another anti- tumor necrosis factor alpha (TNFα) or biologic therapy, including but not limited to Remicade (infliximab), Simponi (golimumab), Tysabri (natalizumab), Entyvio (vedolizumab).
    • Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
    • Patient with a current diagnosis of indeterminate colitis, proctitis, or with a current diagnosis and/or have a history of Crohn's disease.
    • Patient with other tumor necrosis factor (TNF) immune-modulated disease.
    • Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
    • A female patient is pregnant or breast-feeding.
    • Patient is currently participating in another prospective study including controlled clinical trials and observational studies

More on this trial

Clinical Trials.gov