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Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Treatment Algorithm | Active Comparator | 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 | Other | Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Treatment Algorithm | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Crohn's Disease-related complications at two years | Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months. | Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients at one year and two years who are in Deep Remission without disease progression | Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for Crohn's Disease (resection, bypass, stricturoplasty). | 1 year, 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian G Feagan, MD | Robarts Clinical Trials - Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
| Carle Foundation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23856361 | Background | 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. | |
| 18848553 | Background |
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The study is site randomization not subject.
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algorithm
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|
|
| Conventional Step-care Algorithm | Other | Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score. |
|
| six months, 12 months |
| 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. | Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. | six months, 12 months |
| Proportion of patients at one year and two years who are in Deep Remission |
Deep remission defined as a Harvey-Bradshaw Index (HBI) less than or equal to 4, no steriods for the treatment of Crohn's Disease, and normal C-reactive protein |
| 1 year, 2 years |
| Proportion of patients at one year and 2 years who are in Clinical Remission | Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4. | 1 year, 2 years |
| Change in C-reactive protein | 6 months, 1 year, 2 years |
| Change in health related QoL, patient and physician global rating | The EuroQoL instrument [EQ-5D] will be used to measure quality of life. | 6 months, 1 year, 2 years |
| Patient and physician satisfaction | At the completion of study participation, subjects and physicians in both treatment groups will be asked to complete a satisfaction questionnaire regarding the information provided and their overall satisfaction with the approach to the management of CD. The physicians will also be asked if they would recommend the CD treatment algorithm to their colleagues, and if they think it would be feasible to sustain this algorithm within their practice setting. | 2 years |
| Urbana |
| Illinois |
| 61801 |
| United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| Duane Sheppard, GI Inc. | Dartmouth | Nova Scotia | B2Y 4G8 | Canada |
| The Office of Dr. Bruce Musgrave | Kentville | Nova Scotia | B4N 0A3 | Canada |
| Dr. Fashir Medical Inc. | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Sudbury Endoscopy Center | Greater Sudbury | Ontario | P3C 5K6 | Canada |
| S. and T. Shulman Medicine Professional Corporation | North Bay | Ontario | P1B 2H3 | Canada |
| Oravec Medicine Professional Corporation | Oshawa | Ontario | L1J 2J9 | Canada |
| The Office of Dr. Pierre Laflamme | Saint-Charles-Borromée | Quebec | J6E 2C3 | Canada |
| Verein fur Wissenschaft und Fortbildung | Oldenburg | Lower Saxony | 26123 | Germany |
| Praxis fur Gastroenterologie am Bayerischen Platz | Berlin | 10825 | Germany |
| Gastroenterologie Eppendorfer Baum | Hamburg | 20249 | Germany |
| Royal Berkshire NHS Foundation Trust | Reading | Berkshire | RG1 5AN | United Kingdom |
| The Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| The Royal Hampshire County Hospital | Winchester | Hampshire | SO2 5DG | United Kingdom |
| Oxford University Hospitals NHS Foundation - John Radcliffe Hospital | Headington | Oxford | OX3 9DU | United Kingdom |
| University Hospital Coventry | Coventry | West Midlands | CV2 2DX | United Kingdom |
| New Cross Hospital - Royal Wolverhampton NHS Trust | Wolverhampton | West Midlands | WV1 0QP | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | D1406 | United Kingdom |
| 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. |
| 20393175 | Background | 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. |
| 18295023 | Background | 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. |
| 16678077 | Background | 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. |
| 35120657 | Derived | 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. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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