Crohn DiseasePhase 3NCT02332356
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
A Phase 3 study testing azathioprine or adalimumab and infliximab in people with Crohn Disease, run by Tokyo Medical and Dental University at 1 site in Japan.
Trial summary
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- azathioprine or adalimumab and infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2014to Mar 2024
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150)
- Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)
Who cannot join
- Contraindication for infliximab, adalimumab, or azathioprine
- Lactating woman
- Presence of malignancy
- Within 3 month from intestinal surgery
- Presence of an end stoma
- Planned surgery
Trial locations and contacts
1 site in 1 country.
Japan1 site
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
Tokyo, 113-8519
About this study
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.
- Conditions
- Crohn Disease
- Being tested
- azathioprine or adalimumab and infliximab
- Keywords
- Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azathioprine or adalimumab and infliximabDrug
| Study group | Role | What they receive |
|---|---|---|
| step up | Active comparator | Procedure: MREC patients receive therapeutic step up Receives: Drug: azathioprine or adalimumab and infliximab |
| observation step up | No intervention | Not described |
| step down | Active comparator | Procedure: MREC patients receive therapeutic step down Receives: Drug: azathioprine or adalimumab and infliximab |
| observation step down | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of clinical remission at 104 weeks.
Measured: 104 weeks
Secondary outcomes (1)
The rate of hospitalization and operation
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical and Dental University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toshimitsu Fujii, MD PhD, Tokyo Medical and Dental University
- Investigators
- Toshimitsu Fujii, Principal investigator, Tokyo Medical and Dental University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332356
- Sponsor's protocol ID
- MREC study
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2015
- Last updated
- 27 Nov 2023
- Results posted
- No
Publications
Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13.
PubMed 24732015Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25.
PubMed 21484957
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02332356
- Acronym / sponsor ID
- MREC study
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tokyo Medical and Dental UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Jan 2015 (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.
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| step up | Active comparator | Drug: azathioprine or adalimumab and infliximabProcedure: MREC patients receive therapeutic step up |
| observation step up | No intervention | – |
| step down | Active comparator | Drug: azathioprine or adalimumab and infliximabProcedure: MREC patients receive therapeutic step down |
| observation step down | No intervention | – |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150)
- Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)
Key exclusion criteria (6 listed)
- Contraindication for infliximab, adalimumab, or azathioprine
- Lactating woman
- Presence of malignancy
- Within 3 month from intestinal surgery
- Presence of an end stoma
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 |
|---|---|---|
| azathioprine or adalimumab and infliximab | Drug | step down, step up |
Primary outcome
The rate of clinical remission at 104 weeks.
Time frame: 104 weeks
1 secondary outcome
The rate of hospitalization and operation
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 24732015Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13.
- Background: PubMed 21484957Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25.
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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.
Toshimitsu Fujii principal investigator
Tokyo Medical and Dental University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azathioprine or adalimumab and infliximab in people with Crohn Disease, run by Tokyo Medical and Dental University at 1 site in Japan.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The rate of clinical remission at 104 weeks. (time frame: 104 weeks). 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 NCT02332356, 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 27 Nov 2023.