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A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response With Weekly ADAlimumab in Crohn's Disease Subjects With Secondary Loss of Response (PRADA) (NCT02896985)

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).
Ages eligible for Study
18 Years to 99 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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.

23 locations

Canada (23)
  • University of Calgary /ID# 157893
    not yet recruiting
    Calgary, Canada, T2N
  • Dr. Mark Lee Medicine Professional Corporation /ID# 153127
    recruiting
    Cambridge, Canada, N1R 0B6
  • University of Alberta /ID# 155224
    not yet recruiting
    Edmonton, Canada, T6G 2B7
  • CSSS de la MonteCentre de recherche Hopital Charles-Le Moyne /ID# 162724
    recruiting
    GreenField Park, Canada, J4V 2H1
  • Queen Elizabeth II Health Sciences Center /ID# 152454
    not yet recruiting
    Halifax, Canada, B3H 2Y9
  • McMaster University Medical Centre /ID# 151996
    recruiting
    Hamilton, Canada, L8S 4K1
  • CISSS de Chaudiere-Appalaches, site Hotel-Dieu de Levis /ID# 155493
    not yet recruiting
    Levis, Canada, G6V 3Z1
  • London Health Sciences Centre /ID# 152508
    recruiting
    London, Canada, N6A 5A5
  • Hospital Maisonneuve-Rosemont /ID# 155184
    recruiting
    Montreal, Canada, H1T 2M4
  • McGill University Health Center (MUHC) /ID# 151997
    recruiting
    Montreal, Canada, H3G 1A4
  • Clinique MEDI-CLE /ID# 153772
    not yet recruiting
    Montreal, Canada, H3P 3E5
  • Columbia Gastroenterology Management Ltd /ID# 152507
    not yet recruiting
    New Westminster, Canada, V3L 3W5
  • Palermo Professional Centre /ID# 168268
    not yet recruiting
    Oakville, Canada, L6M 4J2
  • Taunton surgical centre /ID# 151998
    not yet recruiting
    Oshawa, Canada, L1H 7K4
  • The Ottawa Hospital Cancer Centre /ID# 153771
    not yet recruiting
    Ottawa, Canada, K1H 8L6
  • Royal University of Saskatchewan (CTSU) /ID# 162316
    not yet recruiting
    Saskatoon, Canada, S7N 0W8
  • CHUS Hotel Dieu /ID# 157976
    not yet recruiting
    Sherbrooke, Canada, J1G 2E8
  • Mount Sinai Hospital-Toronto /ID# 155262
    recruiting
    Toronto, Canada, M5G 1X5
  • Toronto Digestive Disease Associates /ID# 152509
    not yet recruiting
    Vaughan, Canada, L4L 4Y7
  • Discovery Clinical Services, Ltd. /ID# 154682
    recruiting
    Victoria, Canada, V8T 5G4
  • Earle Morgan Professional Medicine Corporation /ID# 163125
    not yet recruiting
    Windsor, Canada, N8W 1E6
  • Dr. Rahman Bacchus Medicine Corporation /ID# 163145
    withdrawn
    Windsor, Canada, N8Y 4C9
  • Dr. Rahman Bacchus Medicine Corporation /ID# 163137
    not yet recruiting
    Windsor, Canada, N8Y 4X9
Status:
recruiting
Type:
Observational
Phase:
-
Start:
15 December, 2016
Updated:
11 October, 2017
Participants:
100
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