Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy - Full Text View

Purpose

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

Condition	Intervention	Phase
Crohn's Disease	Other: Enhanced Treatment Algorithm Other: Conventional Step-care Algorithm	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:

Risk of CD-related complications at one-year, measured at the practice level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
CD-related complications include (1) CD-related hospitalizations for CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, excluding hospitalization for side effects of study medication), and (2) Bowel damage events not requiring hospitalization (such as symptomatic bowel obstruction, cutaneous fistula, abscess).

Secondary Outcome Measures:

Risk of CD-related complications (including CD-related hospitalizations and surgeries at 6 months.) [ Time Frame: six months ] [ Designated as safety issue: No ]
CD-related complications include (1) CD-related hospitalizations for CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, excluding hospitalization for side effects of study medication), and (2) Bowel damage events not requiring hospitalization (such as symptomatic bowel obstruction, cutaneous fistula, abscess).

Other Outcome Measures:

Proportion of patients at one year who are in Deep Remission without disease progression [ Time Frame: twelve months ] [ Designated as safety issue: No ]
Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for CD (resection, bypass, stricturoplasty).

Estimated Enrollment:	120
Study Start Date:	January 2013
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Other: 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. Other Name: Adalimumab
Conventional Step-care Algorithm Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the HBS	Other: Conventional Step-care Algorithm Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the HBS.

Arms

Assigned Interventions

Active Comparator: 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.

Other: 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.

Other Name: Adalimumab

Conventional Step-care Algorithm

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the HBS

Other: Conventional Step-care Algorithm

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented diagnosis of CD
Written informed consent must be obtained and documented.
Willing to utilize study supply of adalimumab provide 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.
Currently participating, or planning to participate in a study involving investigational product within 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698307

Contacts

Contact: Joan Morris, MHSc

519.851.2092

jmorris@robarts.ca

Sponsors and Collaborators

University of Western Ontario, Canada

Investigators

Principal Investigator:

Brian G Feagan, MD

Robarts Clinical Trials - Western University

More Information

Publications:

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. 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.

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 JC, van der Woude J, Ochsenkühn 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):660-7.

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. Erratum in: Clin Gastroenterol Hepatol. 2006 Jul;4(7):931.

Responsible Party:	University of Western Ontario, Canada
ClinicalTrials.gov Identifier:	NCT01698307 History of Changes
Other Study ID Numbers:	RP1202
Study First Received:	September 28, 2012
Last Updated:	September 28, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Netherlands: Ministry of Health, Welfare and Sport United States: Food and Drug Administration

Keywords provided by University of Western Ontario, Canada:

Crohn's Disease
Deep Remission
Complications

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antimetabolites

Adalimumab
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013

Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy (REACT2)