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|
- 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 disease/LOR defined as a PRO2 score > 14 and the presence of active inflammation (confirmed with a CRP > 5 and/or a fecal calprotectin of greater than 250µg/g.
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
- 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.
- University of Calgary /ID# 157893not yet recruitingCalgary, Canada, T2P 1H9
- Mark Lee, MD. Cambridge, CA /ID# 153127recruitingCambridge, Canada, N1S 2M6
- University of Alberta /ID# 155224not yet recruitingEdmonton, Canada, T6G 2B7
- CSSS de la MonteCentre de recherche Hopital Charles-Le Moyne /ID# 162724not yet recruitingGreenField Park, Canada, J4V 2H1
- Queen Elizabeth II Health Sciences Center /ID# 152454not yet recruitingHalifax, Canada, B3H 2Y9
- McMaster University Medical Centre /ID# 151996recruitingHamilton, Canada, L8S 4K1
- CISSS de Chaudiere-Appalaches, site Hotel-Dieu de Levis /ID# 155493not yet recruitingLevis, Canada, G6V 3Z1
- London Health Sciences Centre /ID# 152508recruitingLondon, Canada, N6A 5A5
- Hospital Maisonneuve-Rosemont /ID# 155184not yet recruitingMontreal, Canada, H1T 2M4
- McGill University Health Center (MUHC) /ID# 151997recruitingMontreal, Canada, H3G 1A4
- Centre Medical L'Enjeu /ID# 153772not yet recruitingMontreal, Canada, H3P 3E5
- Columbia Gastroenterology Management Ltd /ID# 152507not yet recruitingNew Westminster, Canada, V3L 3W5
- Taunton surgical centre /ID# 151998not yet recruitingOshawa, Canada, L1H 7K4
- The Ottawa Hospital /ID# 153771not yet recruitingOttawa, Canada, K1H 8L6
- Royal University of Saskatchewan (CTSU) /ID# 162316not yet recruitingSaskatoon, Canada, S7N 0W8
- CHUS Hotel Dieu /ID# 157976not yet recruitingSherbrooke, Canada, J1G 2E8
- Mount Sinai Hospital-Toronto /ID# 155262recruitingToronto, Canada, M5G 1X5
- Toronto Digestive Disease Associates /ID# 152509not yet recruitingVaughan, Canada, L4L 4Y7
- Discovery Clinical Services, Ltd. /ID# 154682recruitingVictoria, Canada, V8T 5G4
- Earle Morgan Professional Medicine Corporation /ID# 163125not yet recruitingWindsor, Canada, N8W 1E6
- Dr. Rahman Bacchus Medicine Corporation /ID# 163145withdrawnWindsor, Canada, N8Y 4C9
- Dr. Rahman Bacchus Medicine Corporation /ID# 163137not yet recruitingWindsor, Canada, N8Y 4X9
15 December, 2016
14 August, 2017