UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016014 |
|---|---|
| Receipt number | R000018617 |
| Scientific Title | Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2021/01/15 16:44:16 |
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Basic information
Public title
Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches
Acronym
Magnifying endoscopy, adalimumab and mucosal healing
Scientific Title
Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches
Scientific Title:Acronym
Magnifying endoscopy, adalimumab and mucosal healing
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study patients who achieved endoscopic remission (mucosal healing) at week 12 of adalimumab treatment will be followed up with the conventional endoscopy and magnifying endoscopy by week 52. The percentage of patients who achieved mucosal healing at week 52 will be compared between patients with mucosal healing on the basis of conventional endoscopy ("CE-remission group") and those with normalized mucosa on the basis of magnifying endoscopy ("ME-remission Group") at week 12.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients who achieved endoscopic remission
The percentage of patients who achieved CE remission at week 52 will be calculated for subgroups of patients who achieved ME remission and CE remission at week 12.
Key secondary outcomes
Percentages of patients who achieved ME remission at weeks 12 and 52
Percentages of patients who achieved CE remission at weeks 12 and 52
Percentages of patients who achieved ME remission and a CDAI score of <150 at weeks 12 and 52
Endoscopic assessment of colonic segments other than terminal ileum (SES-CD) at weeks 12 and 52
Rates of all-cause hospitalization and CD-related hospitalization by week 52 in patients who achieved ME remission and those who achieved CE remission only.
Correlations between clinical remission (CDAI/HBI), inflammatory response (CRP, etc.) and ME remission (normalization of PP structure).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients achieving mucosal healing with magnifying endoscopy
Interventions/Control_2
Patients achieving mucosal healing with conventional endoscopy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female patients ranging 16 to 75 years of age who have active Crohn's disease that is indicated for the treatment with Humira using the recommended dosing regimens.
Patients who have or not undergone anti-TNF alpha antibody therapy.
Patients who can undergo the conventional and magnifying endoscopy at baseline and weeks 12 and 52.
Key exclusion criteria
severe infection
active tuberculosis
demyelinating disease
congestive heart failure
enteral nutrition with more than 1200 kcal
primary failure with infliximab
administration of investigational new drug within 24 weeks
unsettled treatment with antibiotics, azathioprine, mercaptoprine, methotrexate within 28 days and with steroids within 14 days
treatment with prednisolone at more than 40 mg dose, cyclosporine, tacrolimus, alkylating agaents
leukocytoapheresis within 8 weeks
aritifical anus and ileoanal pouch
severe stricture, fistula and abcess
total parenteral or entral nutrition
exclusion by responsible persons
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
8528501
Address
1-7-1 Nagasaki
TEL
095-819-7336
hajimei2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
8528501
Address
1-7-1 Nagasaki
TEL
095-819-7336
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki university hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197481
kmatsu@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.mh.nagasaki-u.ac.jp/research/rinsho/patients/open_gastro.html
Number of participants that the trial has enrolled
1
Results
none
Results date posted
| 2021 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018617
