UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007343
Receipt number R000008656
Scientific Title The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Date of disclosure of the study information 2012/02/21
Last modified on 2019/09/04 17:49:49

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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 or person

Institute

Tohoku University Graduate School of Medicine (Tohoku University Hospital)

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name