Clinical trial NCT01698307: Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy
Official title: A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Deep Remission
Complications
Lead sponsor: Alimentiv Inc.
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 1095
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: algorithm
Primary purpose: TREATMENT

Brief summary: Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

Detailed description: Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity.

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.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of CD
* 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:

* Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
* 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

Primary outcomes:
measure: Risk of Crohn's Disease-related complications at two years
timeFrame: 2 years
Secondary outcomes:
measure: Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.
timeFrame: six months, 12 months
measure: Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months.
timeFrame: six months, 12 months
Other outcomes:
measure: Proportion of patients at one year and two years who are in Deep Remission without disease progression
timeFrame: 1 year, 2 years
measure: Proportion of patients at one year and two years who are in Deep Remission
timeFrame: 1 year, 2 years
measure: Proportion of patients at one year and 2 years who are in Clinical Remission
timeFrame: 1 year, 2 years
measure: Change in C-reactive protein
timeFrame: 6 months, 1 year, 2 years
measure: Change in health related QoL, patient and physician global rating
timeFrame: 6 months, 1 year, 2 years
measure: Patient and physician satisfaction
timeFrame: 2 years
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Dartmouth
country: Canada
facility: Duane Sheppard, GI Inc.
state: Nova Scotia
city: Kentville
country: Canada
facility: The Office of Dr. Bruce Musgrave
state: Nova Scotia
city: Sydney
country: Canada
facility: Dr. Fashir Medical Inc.
state: Nova Scotia
city: North Bay
country: Canada
facility: S. and T. Shulman Medicine Professional Corporation
state: Ontario
city: Oshawa
country: Canada
facility: Oravec Medicine Professional Corporation
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Endoscopy Center
state: Ontario
city: Saint-Charles-Borromée
country: Canada
facility: The Office of Dr. Pierre Laflamme
state: Quebec
city: Oldenburg
country: Germany
facility: Verein fur Wissenschaft und Fortbildung
state: Lower Saxony
city: Berlin
country: Germany
facility: Praxis fur Gastroenterologie am Bayerischen Platz
city: Hamburg
country: Germany
facility: Gastroenterologie Eppendorfer Baum
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
state: Berkshire
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
state: Dorset
city: Winchester
country: United Kingdom
facility: The Royal Hampshire County Hospital
state: Hampshire
city: Headington
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
state: Oxford
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: West Midlands
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital - Royal Wolverhampton NHS Trust
state: West Midlands
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Robarts Clinical Trials - Western University
name: Brian G Feagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.