UMIN-CTR Clinical Trial

Basic information
Public title	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Acronym	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Scientific Title	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Scientific Title:Acronym	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The occurrence of relapse (Relapse was defined as either the increase of CDAI score of more than 70 points compared with the score at week 8, or the need for therapy to induce remission.)
Key secondary outcomes	1) The rate of clinical response (CDAI score of less than 220) at week 8 2) The rate of mucosal healing at week 24 and 48 3) Safety assessment etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Interventions/Control_2	Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligible patients have active Crohn's disease with a CDAI score of 220 to 450 points, and have a clinical response to anti-TNF antibody with a CDAI score of less than 220 at week 8. This study is especially aimed at the patients who require dose escalation of 1st anti-TNF antibody or switch to 2nd anti-TNF antibody, after loss of response and/or intolerance to 1st anti-TNF antibody.
Key exclusion criteria	(1) anti-TNF antibody contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, or the protein of mouse origin 4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5) Patients with congestive heart failure (2) Pregnant or likely to be pregnant women (3) Pregnant or lactating women (4) Patients < 20 years of age (5) Patients not approving the study consent (6) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (7) Patients with active hepatitis B or C (8) Patients with human immunodeficiency virus (9) Patients with malignancy (10) Patients judged as inadequate at the discretion of physicians
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuya Endo
Organization	Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division name	Division of Gastroenterology
Zip code
Address	1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL	022-717-7171
Email	kendo@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisashi Shiga
Organization	Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division name	Division of Gastroenterology
Zip code
Address	1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL	022-717-7171
Homepage URL
Email	shiga@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	2012 Year 02 Month 21 Day

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	Completed
Date of protocol fixation	2011 Year 11 Month 18 Day
Date of IRB	2011 Year 11 Month 18 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 02 Month 21 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008656