search
Back to results

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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Enhanced Treatment Algorithm
Conventional Step-care Algorithm
Sponsored by
Alimentiv Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Deep Remission, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Hospital
  • Carle Foundation Hospital
  • Louisiana Research Center, LLC
  • Asheville Gastroenterology Associates, PA
  • Scott and White Memorial Hospital
  • Duane Sheppard, GI Inc.
  • The Office of Dr. Bruce Musgrave
  • Dr. Fashir Medical Inc.
  • S. and T. Shulman Medicine Professional Corporation
  • Oravec Medicine Professional Corporation
  • Sudbury Endoscopy Center
  • The Office of Dr. Pierre Laflamme
  • Verein fur Wissenschaft und Fortbildung
  • Praxis fur Gastroenterologie am Bayerischen Platz
  • Gastroenterologie Eppendorfer Baum
  • Royal Berkshire NHS Foundation Trust
  • The Royal Bournemouth Hospital
  • The Royal Hampshire County Hospital
  • Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
  • University Hospital Coventry
  • New Cross Hospital - Royal Wolverhampton NHS Trust
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Enhanced Treatment Algorithm

Conventional Step-care Algorithm

Arm Description

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.

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 28, 2012
Last Updated
November 4, 2021
Sponsor
Alimentiv Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01698307
Brief Title
Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy
Acronym
REACT2
Official Title
A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2014 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimentiv Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, Deep Remission, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
algorithm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1095 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Treatment Algorithm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Step-care Algorithm
Arm Type
Other
Arm Description
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
Intervention Type
Other
Intervention Name(s)
Enhanced Treatment Algorithm
Other Intervention Name(s)
Adalimumab
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Step-care Algorithm
Intervention Description
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
Primary Outcome Measure Information:
Title
Risk of Crohn's Disease-related complications at two years
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.
Description
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.
Time Frame
six months, 12 months
Title
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.
Description
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.
Time Frame
six months, 12 months
Other Pre-specified Outcome Measures:
Title
Proportion of patients at one year and two years who are in Deep Remission without disease progression
Description
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).
Time Frame
1 year, 2 years
Title
Proportion of patients at one year and two years who are in Deep Remission
Description
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
Time Frame
1 year, 2 years
Title
Proportion of patients at one year and 2 years who are in Clinical Remission
Description
Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4.
Time Frame
1 year, 2 years
Title
Change in C-reactive protein
Time Frame
6 months, 1 year, 2 years
Title
Change in health related QoL, patient and physician global rating
Description
The EuroQoL instrument [EQ-5D] will be used to measure quality of life.
Time Frame
6 months, 1 year, 2 years
Title
Patient and physician satisfaction
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian G Feagan, MD
Organizational Affiliation
Robarts Clinical Trials - Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Duane Sheppard, GI Inc.
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2Y 4G8
Country
Canada
Facility Name
The Office of Dr. Bruce Musgrave
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 0A3
Country
Canada
Facility Name
Dr. Fashir Medical Inc.
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
S. and T. Shulman Medicine Professional Corporation
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Oravec Medicine Professional Corporation
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2J9
Country
Canada
Facility Name
Sudbury Endoscopy Center
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 5K6
Country
Canada
Facility Name
The Office of Dr. Pierre Laflamme
City
Saint-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 2C3
Country
Canada
Facility Name
Verein fur Wissenschaft und Fortbildung
City
Oldenburg
State/Province
Lower Saxony
ZIP/Postal Code
26123
Country
Germany
Facility Name
Praxis fur Gastroenterologie am Bayerischen Platz
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Gastroenterologie Eppendorfer Baum
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
The Royal Hampshire County Hospital
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO2 5DG
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
New Cross Hospital - Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV1 0QP
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
D1406
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study is site randomization not subject.
Citations:
PubMed Identifier
23856361
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.
Results Reference
background
PubMed Identifier
18848553
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.
Results Reference
background
PubMed Identifier
20393175
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.
Results Reference
background
PubMed Identifier
18295023
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.
Results Reference
background
PubMed Identifier
16678077
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. Erratum In: Clin Gastroenterol Hepatol. 2006 Jul;4(7):931.
Results Reference
background
PubMed Identifier
35120657
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.
Results Reference
derived

Learn more about this trial

Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

We'll reach out to this number within 24 hrs