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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007047
Receipt No. R000008194
Scientific Title Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Date of disclosure of the study information 2012/01/10
Last modified on 2020/07/18

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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