UMIN-CTR Clinical Trial

Basic information
Public title	Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.
Acronym	Study on the selection of appropriate patients for the dose escalation of adalimumab.
Scientific Title	Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.
Scientific Title:Acronym	Study on the selection of appropriate patients for the dose escalation of adalimumab.
Region	Japan

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

Objectives
Narrative objectives1	To define the appropriate patients for the dose escalation of adalimumab in Crohn' s disease therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of clinical remission rates at 1 year after randomization between dose escalation group and non-dose escalation group.
Key secondary outcomes	Comparison of CDAI/CRP, trough/AAA concentration in blood, and endoscopic remission rate at 24, 48 weeks after randomization. Predictive factors for effectiveness of adalimumab dose escalation.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dose escalation group Administration of Adalimumab 80 mg every other week
Interventions/Control_2	Non-dose escalation group Administration of Adalimumab 40 mg every other week
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Japanese individuals with Crohn's disease who received induction treatment with adalimumab (160/80 mg at Weeks 0/2), achieved CDAI<=150 AND a decrease in CDAI of >=70 at 4 weeks after initial dose and then lost response. The lost response is defined as "CRP>0.3 more than 2 times and CRP<3 all the time" or "175<=CDAI<300".
Key exclusion criteria	1.Patients who correspond to the warning or contraindication of the package insert of adalimumab 2.Patients under breast-feeding 3.Patients who do not agree to join the study 4.Patients with previous use of anti-TNF therapy 5.Patients who has neoplasm 6.Patients who had intestinal resection within 6 months 7.Patients with short bowel syndrome 8.When the doctor in charge determines that the patients are not suitable for the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Suzuki
Organization	Toho University Medical Center Sakura Hospital
Division name	Department of Internal Medicine
Zip code
Address	564-1 Shimoshizu, Sakura, Chiba, Japan
TEL	043-462-8811
Email	yasuo-suzuki@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuo Suzuki
Organization	Toho University Medical Center Sakura Hospital
Division name	Department of Internal Medicine
Zip code
Address	564-1 Shimoshizu, Sakura, Chiba, Japan
TEL	043-462-8811
Homepage URL
Email	yasuo-suzuki@sakura.med.toho-u.ac.jp

Sponsor
Institute	Toho University Medical Center Sakura Hospital
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	東邦大学医療センター佐倉病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 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	2016 Year 06 Month 08 Day
Date of IRB	2016 Year 08 Month 19 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 26 Day
Last modified on	2021 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027990