Crohn's DiseasePhase 4REACTNCT01030809
Trial of a Treatment Algorithm for the Management of Crohn's Disease
A Phase 4 study testing Treatment Algorithm for Crohn's Disease in people with Crohn's Disease, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices. 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?
- Treatment Algorithm for Crohn's Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,999 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Dec 2013
- 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 Crohn's disease
- Able to speak and understand English, French or Flemish
- Access to a telephone or email/internet service
- Written informed consent must be obtained and documented
Who cannot join
- Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
- Participating in other investigational studies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Robarts Clinical Trials, Robarts Research Institute
London, Ontario, N6A 5K8
About this study
Official title: A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease
Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.
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. Although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified Optimizing outcomes in CD requires rapid control of inflammation. Intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. Conventional therapy is frequently ineffective in moderate to severe CD, and is often continued for a prolonged time. Consequently, many patients are under-treated. An alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (TNF) antagonists may be optimal. However it is unknown whether this approach is superior to usual care
- Conditions
- Crohn's Disease
- Being tested
- Treatment Algorithm for Crohn's Disease
- Keywords
- Crohn's disease, community based gastroenterology practices Canada and Belgium, Cluster randomization controlled trial, Remission, Corticosteroids, Documented diagnosis of Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Algorithm for Crohn's DiseaseOther
Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care practice | No intervention | Patients managed according to usual care practices |
| Treatment Algorithm | Active comparator | Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm. Receives: Other: Treatment Algorithm for Crohn's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice.
Measured: 24 months
Secondary outcomes (1)
Proportion of patients in remission over study, change in mean HBS; use of CD meds, occurrence of surgery/hospitalization for CD and complications, patients' health related QOL measured by SF-36 & EQ-5D; physician/patient satisfaction with therapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- None (open label)
- Enrolment
- 1,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Brian G Feagan, MD, Principal investigator, Robarts Research Institute - University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030809
- Sponsor's protocol ID
- RP0901
- Acronym
- REACT
- Status last verified
- Mar 2014
- First submitted
- 9 Dec 2009
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, Feagan BG, Jairath V. Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT. Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19.
PubMed 30891808Khanna R, Bressler B, Levesque BG, Zou G, Stitt LW, Greenberg GR, Panaccione R, Bitton A, Pare P, Vermeire S, D'Haens G, MacIntosh D, Sandborn WJ, Donner A, Vandervoort MK, Morris JC, Feagan BG; REACT Study Investigators. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1825-34. doi: 10.1016/S0140-6736(15)00068-9. Epub 2015 Sep 3.
PubMed 26342731
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease
- ClinicalTrials.gov ID
- NCT01030809
- Acronym / sponsor ID
- REACT / RP0901
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, community based gastroenterology practices Canada and Belgium, Cluster randomization controlled trial, Remission, Corticosteroids, Documented diagnosis of Crohn's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,999 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2009 (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 a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.
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. Although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified Optimizing outcomes in CD requires rapid control of inflammation. Intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. Conventional therapy is frequently ineffective in moderate to severe CD, and is often continued for a prolonged time. Consequently, many patients are under-treated. An alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (TNF) antagonists may be optimal. However it is unknown whether this approach is superior to usual care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care practice | No intervention | –Patients managed according to usual care practices |
| Treatment Algorithm | Active comparator | Other: Treatment Algorithm for Crohn's DiseasePractitioners assigned to the intervention arm will be educated on the use of the treatment algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented diagnosis of Crohn's disease
- Able to speak and understand English, French or Flemish
- Access to a telephone or email/internet service
- Written informed consent must be obtained and documented
Key exclusion criteria (2 listed)
- Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
- Participating in other investigational studies
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 |
|---|---|---|
| Treatment Algorithm for Crohn's DiseasePractitioners assigned to the intervention arm will be educated on the use of the treatment algorithm. | Other | Treatment Algorithm |
Primary outcome
Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice.
Time frame: 24 months
1 secondary outcome
Proportion of patients in remission over study, change in mean HBS; use of CD meds, occurrence of surgery/hospitalization for CD and complications, patients' health related QOL measured by SF-36 & EQ-5D; physician/patient satisfaction with therapy.
Time frame: 24 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 20 Mar 2014.
- Derived from this study: PubMed 30891808Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, Feagan BG, Jairath V. Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT. Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19.
- Derived from this study: PubMed 26342731Khanna R, Bressler B, Levesque BG, Zou G, Stitt LW, Greenberg GR, Panaccione R, Bitton A, Pare P, Vermeire S, D'Haens G, MacIntosh D, Sandborn WJ, Donner A, Vandervoort MK, Morris JC, Feagan BG; REACT Study Investigators. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1825-34. doi: 10.1016/S0140-6736(15)00068-9. Epub 2015 Sep 3.
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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 Research Institute - University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment Algorithm for Crohn's Disease in people with Crohn's Disease, run by University of Western Ontario, Canada at 1 site in Canada.
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 4 inclusion and 2 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (time frame: 24 months). 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 NCT01030809, which also lists 2 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 20 Mar 2014.