UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
Title of the study (Brief title)	The Efficacy of Adalimumab
Region	Japan

Condition
Condition	Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety of Adalimumab conbined elemental diet therapy for Crohn's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1)Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29. 2)Elental(1 kcal/ml; 80g/300ml)
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
Key exclusion criteria	1)The patient who has internal fistula 2)The patient who is planning to have an operation 3)The patient who is short bowel syndorome 4)The patient of contraindication for adalimumab or Elental 5)The case which is hard to get the patient's consent 6)The patient who was judged for unsuitable by responsibility doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Kenji Watanabe
Organization	Osaka City University Gradatescool of Medicine
Division name	Gastroenterology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
Email

Public contact
Name of contact person
Organization	Osaka City University Gradatescool of Medicine
Division name	Gastroenterology
Address
TEL
Homepage URL
Email	nkamata@med.osaka-cu.ac.jp

Sponsor
Institute	Kenji Watanabe
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2010 Year 10 Month 27 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 13 Day
Last modified on	2018 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006812