UMIN-CTR Clinical Trial

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
Email	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
Email	hajimei2002@yahoo.co.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018617