![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000017781 |
Receipt No. | R000020594 |
Scientific Title | Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease |
Date of disclosure of the study information | 2015/06/02 |
Last modified on | 2019/06/05 |
Basic information | ||
Public title | Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease | |
Acronym | MREC study | |
Scientific Title | Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease | |
Scientific Title:Acronym | MREC study | |
Region |
|
Condition | |||
Condition | Crohn's disease | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with 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. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | The primary endpoint is the rate of clinical remission(CDAI<150) at 104 weeks. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 4 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
|
||
Interventions/Control_1 | Step up active: step up arm:
patients receive therapeutic step up |
||
Interventions/Control_2 | No Intervention: Standard care arm | ||
Interventions/Control_3 | Step down active: step down arm:
patients receive therapeutic step down |
||
Interventions/Control_4 | No Intervention: Standard care arm | ||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 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 | Contraindication for infliximab, adalimumab, or azathioprine
Lactating woman Presence of malignancy Within 3 month from intestinal surgery Presence of an end stoma Planned surgery |
|||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | 113-8519 | ||||||
Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo Japan | ||||||
TEL | 03-5803-5877 | ||||||
tfujii.gast@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Gastroenterology and Hepatology | ||||||
Zip code | 113-8519 | ||||||
Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo Japan | ||||||
TEL | 03-5803-5877 | ||||||
Homepage URL | |||||||
tfujii.gast@tmd.ac.jp |
Sponsor | |
Institute | Department of Gastroenterology and Hepatology
Tokyo Medical and Dental University |
Institute | |
Department |
Funding Source | |
Organization | The Japanese Gastroenterological Association |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Tokyo Medical and Dental University Hospital of Medicine, Clinical Reserch Center |
Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo Japan |
Tel | 03-5803-4575 |
tiken.crc@tmd.ac.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT02332356 |
Org. issuing International ID_1 | ClinicalTrials.gov |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 東京医科歯科大学医学部附属病院(東京都)、北海道大学病院(北海道)、山梨大学医学部附属病院(山梨県)、武蔵野赤十字病院(東京都)、草加市立病院(埼玉県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020594 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |