UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail)
Title of the study (Brief title)	CERISIER-Trial;Combination of Elemental Dietary Therapy and Infliximab for Secondary Failure to Infliximab in Patients with Crohn's Disease
Region	Japan

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

Objectives
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

Assessment
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)

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	NO
Concealment	Central registration

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Mamoru Watanabe
Organization	Japanese Society of Inflammatory Bowel Disease
Division name	Board Chairman
Address	Kagurazaka2-12-1-502, Shinjyuku-ku, Tokyo
TEL	03-3268-6423
Email	jimukyoku@jsibd.jp

Public contact
Name of contact person	Akiko Ikeda
Organization	Japanese Society of Inflammatory Bowel Disease
Division name	a secretariat
Address	Kagurazaka2-12-1-502, Shinjyuku-ku, Tokyo
TEL	03-3268-6423
Homepage URL
Email	jimukyoku@jsibd.jp

Sponsor
Institute	Japanese Society of Inflammatory Bowel Disease
Institute
Department

Funding Source
Organization	EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

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）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 17 Day
Last modified on	2017 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011774