UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease
Acronym	ADA2 study
Scientific Title	Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease
Scientific Title:Acronym	ADA2 study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	effects and predictive value of double dose of adalimumab
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	effective rates
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	double dose of adalimumab
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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	loss of response of adalimumab
Key exclusion criteria	refractory patients for adalimumab
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center
Division name	Gastroenterology and Hepatology
Zip code
Address	1981 Kamoda,Kawagoe City, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center
Division name	Gastroenterology and Hepatology
Zip code
Address	1981 Kamoda,Kawagoe City, Japan
TEL	0492283564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	7
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	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 11 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025662