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Ucanada

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

    Status Recruiting
    Related Conditions

Enrollment Details

Phases: 

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

This is a type IV phase trial.

Protocol ID
P15-325

Brief summary

Top

To evaluate the real-life effect after 1 year of adalimumab treatment 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: 27

0
Calgary, AB
1
Edmonton, AB
2
New Westminster, BC
3
Vancouver, BC
4
Vancouver, BC
5
Victoria, BC
6
Victoria, BC
7
Fredericton, NB
8
St. John, NB
9
Brampton, ON
10
Hamilton, ON
11
Oshawa, ON
12
Ottawa, ON
13
Toronto, ON
14
Toronto, ON
15
Windsor, ON
16
Windsor, ON
17
Chicoutimi, QC
18
Levis, QC
19
Montreal, QC
20
Montreal, QC
21
Montreal, QC
22
Montreal, QC
23
Quebec, QC
24
Sherbrooke, QC
25
Quebec, QC
26
Saskatoon, SK
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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:
      1.a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
      2.a Mayo rectal bleeding subscore ≥ 2 and a calprotectine value greater than 250 µg/gr.
    • Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
    • If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice
    • Patient has previously received adalimumab.
    • Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
    • 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, ulcerative proctitis only, 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