UMIN-CTR Clinical Trial

Basic information
Public title	Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Acronym	Effect of adacolumn and adalimumab combination therapy for Crohn's disease
Scientific Title	Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Scientific Title:Acronym	Effect of adacolumn and adalimumab combination therapy for Crohn's disease
Region	Japan

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

Objectives
Narrative objectives1	Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Remission induction rate 11 weeks after the start of therapy. Remission rate 104 weeks after the start of therapy.
Key secondary outcomes	Remission period CT or CT enteroclysis/enterography Change of the CRP Safety

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adacolumn and adalimumab combination therapy for 10 weeks. Adalimumab single therapy for remain 94 weeks.
Interventions/Control_2	Adacolumn single therapy for 104 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	12 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	The patient that it was judged that keeping blood access was possible. The patient that agreed this study.
Key exclusion criteria	Below 2,000 / mm3 granulocyte count Severe infection Severe heart disease Severe Renal disease Systolic blood pressure less than 80mmHg patient with suspected or currently pregnant Increased intensity of extreme dehydration or coagulation system Severe anemia Malignant tumor Short-bowel syndrome Artificial anus External fistula Ileus or svere stenosis of the intestine Extraintestinal complications Recent use of steroid, 5-Aminosalicylic acid, immunomodulator, biologics, elemental diet Recent operation
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Hashimoto
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2241
Email

Public contact
Name of contact person	1st name Middle name Last name Shinichi Hashimoto
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2241
Homepage URL
Email	has-333@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
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	山口大学医学部付属病院　Yamaguchi University Hospital セントヒル病院　Sainthill hospital

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 10 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	Terminated
Date of protocol fixation	2010 Year 10 Month 20 Day
Date of IRB	2011 Year 10 Month 26 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 10 Day
Date trial data considered complete	2015 Year 12 Month 10 Day
Date analysis concluded	2015 Year 12 Month 10 Day

Other
Other related information

Management information
Registered date	2012 Year 01 Month 10 Day
Last modified on	2020 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008194