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PRADA

Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )

    Status Recruiting
    Related Conditions
    Crohn's Disease

Enrollment Details

100 Worldwide Enrollment Goal

Phases: 

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

This is a type IV phase trial.

Protocol ID
P15-770

Brief summary

Top

This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).

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

Canada: 25

0
Calgary, AB
1
Edmonton, AB
2
Kelowna, BC
3
New Westminster, BC
4
Vancouver, BC
5
Victoria, BC
6
Victoria, BC
7
Winnipeg, MB
8
Fredericton, NB
9
Halifax, NS
10
Cambridge, ON
11
Hamilton, ON
12
London, ON
13
Oakville, ON
14
Oshawa, ON
15
Ottawa, ON
16
Toronto, ON
17
Windsor, ON
18
Greenfield Park, QC
19
Levis, QC
20
Montreal, QC
21
Montreal, QC
22
Montreal, QC
23
Sherbrooke, QC
24
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

    • Documented diagnosis of Crohn's Disease.
    • Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.
    • Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP ≥ 5 and/or a fecal calprotectin ≥ 250µg/g)
    • Ability of subject to participate fully in all aspects of this clinical trial.
    • Written informed consent must be obtained and documented.
    • Ability of subject to participate fully in all aspects of this clinical trial.
    • Primary non-responders to 16 weeks of adalimumab therapy.
    • Received any investigational drug within the 16 weeks of adalimumab therapy.
    • Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
    • History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
    • Stools positive for Clostridium difficile.
    • Pregnant or lactating women.
    • Current enrolment in any other interventional research study.
    • Presence of perianal or abdominal abscess.

More on this trial

ClinicalTrials.gov