Crohn's DiseasePhase 4REACT2NCT01698307
Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy
A Phase 4 study testing Enhanced Treatment Algorithm and Conventional Step-care Algorithm in people with Crohn's Disease, run by Alimentiv Inc. at 22 sites in 4 countries.
Trial summary
Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Enhanced Treatment Algorithm and Conventional Step-care Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 28 Mar 2014to 16 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Canada7 sites
Duane Sheppard, GI Inc.
Dartmouth, Nova Scotia, B2Y 4G8
Sudbury Endoscopy Center
Greater Sudbury, Ontario, P3C 5K6
The Office of Dr. Bruce Musgrave
Kentville, Nova Scotia, B4N 0A3
S. and T. Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3
Oravec Medicine Professional Corporation
Oshawa, Ontario, L1J 2J9
The Office of Dr. Pierre Laflamme
Saint-Charles-Borromée, Quebec, J6E 2C3
Dr. Fashir Medical Inc.
Sydney, Nova Scotia, B1P 1P3
United Kingdom7 sites
The Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
University Hospital Coventry
Coventry, West Midlands, CV2 2DX
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
Headington, Oxford, OX3 9DU
Nottingham University Hospitals NHS Trust
Nottingham, D1406
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, RG1 5AN
The Royal Hampshire County Hospital
Winchester, Hampshire, SO2 5DG
New Cross Hospital - Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV1 0QP
United States5 sites
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Scott and White Memorial Hospital
Temple, Texas, 76508
Carle Foundation Hospital
Urbana, Illinois, 61801
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Germany3 sites
Praxis fur Gastroenterologie am Bayerischen Platz
Berlin, 10825
Gastroenterologie Eppendorfer Baum
Hamburg, 20249
Verein fur Wissenschaft und Fortbildung
Oldenburg, Lower Saxony, 26123
About this study
Official title: A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease
Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Enhanced Treatment Algorithm, Conventional Step-care Algorithm
- Keywords
- Crohn's Disease, Deep Remission, Complications
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Treatment AlgorithmOther
Also called Adalimumab
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 AlgorithmOther
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Conventional Step-care Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: six months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start28 Mar 2014
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- algorithm
- Masking
- None (open label)
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian G Feagan, MD, Principal investigator, Robarts Clinical Trials - Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698307
- Sponsor's protocol ID
- RP1202
- Acronym
- REACT2
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2012
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is site randomization not subject.
Publications
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.
PubMed 23856361Feagan 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.
PubMed 18848553Colombel 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.
PubMed 20393175D'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.
PubMed 18295023Lichtenstein 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.
PubMed 16678077Ungaro 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.
PubMed 35120657
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease
- ClinicalTrials.gov ID
- NCT01698307
- Acronym / sponsor ID
- REACT2 / RP1202
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Deep Remission, Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- algorithm
| Arm | Type | Receives |
|---|---|---|
| Enhanced Treatment Algorithm | Active comparator | Other: Enhanced Treatment AlgorithmThe 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 | Other: Conventional Step-care AlgorithmStep-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Treatment AlgorithmAlso: AdalimumabThe 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 AlgorithmStep-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score. | Other | Conventional Step-care Algorithm |
Primary outcome
Risk of Crohn's Disease-related complications at two years
Time frame: 2 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 secondary outcomes
Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.
Time frame: 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.
Time frame: six months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 23856361Colombel 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.
- Background: PubMed 18848553Feagan 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.
- Background: PubMed 20393175Colombel 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.
- Background: PubMed 18295023D'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.
- Background: PubMed 16678077Lichtenstein 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.
- Derived from this study: PubMed 35120657Ungaro 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.
- Individual participant dataSharing planned: No. The study is site randomization not subject.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian G Feagan, MD principal investigator
Robarts Clinical Trials - Western University
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enhanced Treatment Algorithm and Conventional Step-care Algorithm in people with Crohn's Disease, run by Alimentiv Inc. at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, United Kingdom, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Crohn's Disease-related complications at two years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698307, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.