UMIN-CTR Clinical Trial

Public title

The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail)

Acronym

CERISIER-Trial;Combination of Elemental Dietary Therapy and Infliximab for Secondary Failure to Infliximab in Patients with Crohn's Disease

Scientific Title

The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail)

Scientific Title:Acronym

CERISIER-Trial;Combination of Elemental Dietary Therapy and Infliximab for Secondary Failure to Infliximab in Patients with Crohn's Disease

Region

Japan

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the effect of elemental dietary therapy in combination with infliximab at 10mg/kg in patients with active Crohn's disease by comparing patients receiving infliximab alone with those treated with IFX/ED combination therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The cumulative rate for successful completion of the scheduled maintenance treatment with IFX infusion at 10 mg/kg every 8 weeks.

Key secondary outcomes

i) The percentage of patients who successfully completed the scheduled maintenance treatment with IFX infusion at 10 mg/kg every 8 weeks at the time of the 56th week of treatment
ii) The percentage of patients with CDAI decreased by 50 points or more at the 16th week of treatment
iii) The percentage of patients with CDAI decreased by 100 points or more between the 8th to the 56th week of treatment
iv) The percentage of patients who achieved remission, as indicated by a CDAI below 150 points, during the 8th to 56th week of treatment
v) Changes in CRP values from baseline between the 8th and 56th week of treatment
vi) Changes in IBDQ scores from baseline at the 16th and 56th weeks of treatment
vii) Changes in SES-CD scores from baseline at the 56th week of treatment (or at the time of treatment discontinuation)
viii) Patient compliance to elemental diet therapy from baseline to the 56th week of treatment (only in the IFX/ED combination therapy group)

Study type

Interventional

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

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination treatment with 10mg/kg IFX (evry 8 weeks) and elemental dietary therapy (900 or1200kcal/day)

Interventions/Control_2

Treatment with 10mg/kg IFX (evry 8 weeks)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients with Crohn's disease that was intractable to 5-mg/kg Infliximab maintenance treatment
2) Patients with two consecutive CDAI values of 175 or more at the time of 5-mg/kg IFX maintenance therapy
3) Patients aged between 16 and under 70 years at the time of giving informed consent
4) Patients accepted regardless of gender or being treated on an inpatient or outpatient basis
5) Patients who were able to give their informed consent in writing were enrolled. For patients aged under 20 years, the written consent should be obtained from a person with parental authority (essential guardians) in addition to the patient's informed consent
6) Patients who showed good compliance (>80%) to Elental therapy during a 1-week receptivity test or patients who a doctor in attendance can judge to have been able to take 3 or more packs of Elental in the past

Key exclusion criteria

1) Patients who have received the treatments stated below during the following treatment periods as indicated by the number of weeks in parentheses
* Biological agents other than infliximab (0-16 weeks)
* Cyclosporine or tacrolimus (0-8 weeks)
* Methotrexate (0-12 weeks)
* Surgery for Crohn's disease (0-16 weeks)
* Total parenteral nutrition (TPN) (0-16 weeks)
* Enteral nutrition at more than 300 kcal/day (0-8 weeks)
* Corticosteroids at doses equivalent to or exceeding 20-mg/day prednisolone (0-4 weeks)
2) Patients who started one of the following therapies or changed the dosage of the drugs
* Corticosteroids (0-4 weeks)
* Azathioprine or mercaptopurine (0-16 weeks)
* Metronidazole or ciprofloxacin (0-4 weeks)
* 5-ASA reagents, including salazosulfapyridine (0-4 weeks)
* Enteral nutrition (0-8 weeks), except the Elental receptivity test period
3) Patients with colorectal or ilecolonic Crohn's disease only with an anastomotic ulcer after enterocolostomy
4) Patients with severe stenosis in the ileum, colon, and rectum
5) Patients who underwent a colostomy
6) Patients with short bowel syndrome
7) Patients who are scheduled to have surgery for Crohn's disease during this trial
8) Patients with severe infectious disease or complications due to infection within 1 year prior to the trial
9) Patients with intra-abdominal abscess
10) Patients with a serum creatinine level of >2.0 mg/dL
11) Patients with a total bilirubin of >3.0 mg/dL or AST or ALT of >100 IU/L
12) Patients with a history of severe drug allergy
13) Patients with malignancy
14) Patients with mental manifestation
15) Patients with a history or complications of drug or alcohol dependency
16) Patients who are pregnant or likely to be pregnant
17) Patients who participated in another clinical trial within 12 weeks prior to the trial
18) Patients who are considered to be unsuitable by the trial investigators

Target sample size

135

Name of lead principal investigator

1st name
Middle name
Last name	Mamoru Watanabe

Organization

Japanese Society of Inflammatory Bowel Disease

Division name

Board Chairman

Zip code

Address

Kagurazaka2-12-1-502, Shinjyuku-ku, Tokyo

TEL

03-3268-6423

Email

jimukyoku@jsibd.jp

Name of contact person

1st name
Middle name
Last name	Akiko Ikeda

Organization

Japanese Society of Inflammatory Bowel Disease

Division name

a secretariat

Zip code

Address

Kagurazaka2-12-1-502, Shinjyuku-ku, Tokyo

TEL

03-3268-6423

Homepage URL

Email

jimukyoku@jsibd.jp

Institute

Japanese Society of Inflammatory Bowel Disease

Institute

Department

Personal name

Organization

EA Pharma Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

札幌厚生病院（北海道）、札幌東徳洲会病院（北海道）、旭川医科大学（北海道）、弘前大学（青森県）、岩手医科大学（岩手県）、新潟大学（新潟県）、自治医科大学（栃木県）、獨協医科大学（栃木県）、埼玉医科大学総合医療センター（埼玉県）、防衛医科大学校（埼玉県）、大森敏秀胃腸科クリニック（埼玉県）、千葉大学（千葉県）、東京慈恵会医科大学附属柏病院（千葉県）、東邦大学佐倉病院（千葉県）、慶應義塾大学（東京都）、東京医科歯科大学（東京都）、東京女子医科大学（東京都）、北里研究所病院（東京都）、北里大学（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、松島クリニック（神奈川県）、大船中央病院（神奈川県）、松田病院（静岡県）、富山県立中央病院（富山県）、家田病院（愛知県）、横山胃腸科病院（愛知県）、よこやまIBDクリニック（愛知県）、四日市羽津医療センター（三重県）、京都大学（京都府）、京都府立医大（京都府）、滋賀医科大学（滋賀県）、東近江総合医療センター（滋賀県）、大阪市立大学（大阪府）、大阪医科大学（大阪府）、大阪大学（大阪府）、大和病院（大阪府）、大阪市立総合医療センター（大阪府）、兵庫医科大学（兵庫県）、川崎医科大学（岡山県）、岡山大学（岡山県）、倉敷中央病院（岡山県）、広島大学（広島県）、松山赤十字病院（愛媛県）、福岡大学筑紫病院（福岡県）、大分赤十字病院（大分県）、佐賀大学（佐賀県）

Date of disclosure of the study information

2013

Year

02

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

10

Month

31

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

17

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

02

Month

17

Day

Last modified on

2017

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011774