Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy
NCT ID: NCT01698307
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1095 participants
INTERVENTIONAL
2014-03-28
2020-04-16
Brief Summary
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Detailed Description
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Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
Interventions
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Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent must be obtained and documented.
* Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.
Exclusion Criteria
* Latex allergy or other conditions in which adalimumab syringes are contraindicated
* Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
* Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD.
* Diagnosis of short bowel syndrome
18 Years
ALL
No
Sponsors
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Alimentiv Inc.
OTHER
Responsible Party
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Principal Investigators
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Brian G Feagan, MD
Role: PRINCIPAL_INVESTIGATOR
Robarts Clinical Trials - Western University
Locations
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Georgetown University Hospital
Washington D.C., District of Columbia, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Duane Sheppard, GI Inc.
Dartmouth, Nova Scotia, Canada
The Office of Dr. Bruce Musgrave
Kentville, Nova Scotia, Canada
Dr. Fashir Medical Inc.
Sydney, Nova Scotia, Canada
Sudbury Endoscopy Center
Greater Sudbury, Ontario, Canada
S. and T. Shulman Medicine Professional Corporation
North Bay, Ontario, Canada
Oravec Medicine Professional Corporation
Oshawa, Ontario, Canada
The Office of Dr. Pierre Laflamme
Saint-Charles-Borromée, Quebec, Canada
Verein fur Wissenschaft und Fortbildung
Oldenburg, Lower Saxony, Germany
Praxis fur Gastroenterologie am Bayerischen Platz
Berlin, , Germany
Gastroenterologie Eppendorfer Baum
Hamburg, , Germany
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
The Royal Hampshire County Hospital
Winchester, Hampshire, United Kingdom
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
Headington, Oxford, United Kingdom
University Hospital Coventry
Coventry, West Midlands, United Kingdom
New Cross Hospital - Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.
Feagan BG, Panaccione R, Sandborn WJ, D'Haens GR, Schreiber S, Rutgeerts PJ, Loftus EV Jr, Lomax KG, Yu AP, Wu EQ, Chao J, Mulani P. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study. Gastroenterology. 2008 Nov;135(5):1493-9. doi: 10.1053/j.gastro.2008.07.069. Epub 2008 Aug 3.
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkuhn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.
Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Chen DM, Pritchard ML, Sandborn WJ. Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol. 2006 May;4(5):621-30. doi: 10.1016/j.cgh.2006.03.002.
Ungaro RC, Colombel JF. Treat to target with ustekinumab for Crohn's disease. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):276-277. doi: 10.1016/S2468-1253(22)00019-X. Epub 2022 Feb 1. No abstract available.
Other Identifiers
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RP1202
Identifier Type: -
Identifier Source: org_study_id