Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

NCT01698307 | Completed Phase 4

• 1 other identifier: RP1202
• Study Type: interventional
• Target: 1,095
• Locations: 4 countries
• Sites: 22

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Deep Remission; Complications

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.

  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.

  six months, 12 months

Other Outcomes (6)

• Proportion of patients at one year and two years who are in Deep Remission without disease progression

  1 year, 2 years

• Proportion of patients at one year and two years who are in Deep Remission

  1 year, 2 years

• Proportion of patients at one year and 2 years who are in Clinical Remission

  1 year, 2 years

Study Arms (2)

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.

Other: Enhanced Treatment Algorithm

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).

Other: Conventional Step-care Algorithm

Interventions

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.

Also known as: Adalimumab

Enhanced Treatment Algorithm

Conventional Step-care Algorithm OTHER

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.

Conventional Step-care Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alimentiv Inc.: lead

Study Sites (22)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Duane Sheppard, GI Inc.

Dartmouth, Nova Scotia, B2Y 4G8, Canada

Location

The Office of Dr. Bruce Musgrave

Kentville, Nova Scotia, B4N 0A3, Canada

Location

Dr. Fashir Medical Inc.

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Sudbury Endoscopy Center

Greater Sudbury, Ontario, P3C 5K6, Canada

Location

S. and T. Shulman Medicine Professional Corporation

North Bay, Ontario, P1B 2H3, Canada

Location

Oravec Medicine Professional Corporation

Oshawa, Ontario, L1J 2J9, Canada

Location

The Office of Dr. Pierre Laflamme

Saint-Charles-Borromée, Quebec, J6E 2C3, Canada

Location

Verein fur Wissenschaft und Fortbildung

Oldenburg, Lower Saxony, 26123, Germany

Location

Praxis fur Gastroenterologie am Bayerischen Platz

Berlin, 10825, Germany

Location

Gastroenterologie Eppendorfer Baum

Hamburg, 20249, Germany

Location

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Location

The Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

The Royal Hampshire County Hospital

Winchester, Hampshire, SO2 5DG, United Kingdom

Location

Oxford University Hospitals NHS Foundation - John Radcliffe Hospital

Headington, Oxford, OX3 9DU, United Kingdom

Location

University Hospital Coventry

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

New Cross Hospital - Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV1 0QP, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, D1406, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 23856361 BACKGROUND

• 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.

  PMID: 18848553 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.

  PMID: 20393175 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.

  PMID: 18295023 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.

  PMID: 16678077 BACKGROUND

• 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.

  PMID: 35120657 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Brian G Feagan, MD

  Robarts Clinical Trials - Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: algorithm

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: March 28, 2014
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (5); GB (7); DE (3)