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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000023735
Receipt No. R000027341
Scientific Title Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study
Date of disclosure of the study information 2016/10/31
Last modified on 2019/03/24

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Basic information
Public title Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study
Acronym TRADE study
Scientific Title Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study
Scientific Title:Acronym TRADE study
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of adalimumab trough level between 80mg EOW- or 40mg EW injection in patients with Crohn's disease treated with dose intensified adalimumab
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes differences of adalimumab trough level between 80mg EOW- or 40mg EW- injection
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EW or EOW injection 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
75 years-old >=
Gender Male and Female
Key inclusion criteria patients with Crohn's disease treated with 80mg EOW adalimumab
Key exclusion criteria Patients with contraindication of adalimumab
Pregnant patients and patients with breast-feeding
Patients with malignancy or after treatment of malignancy
Patients without informed consent
Patients determined not to be sufficient for the entry by physicians
Target sample size 10

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

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

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Japanese Governmental office
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 10 Month 31 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 6
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 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 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 08 Month 23 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027341

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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