UMIN-CTR Clinical Trial

Basic information
Public title	Effect of adalimumab dose escalation in patients with Crohn's disease
Acronym	Effect of adalimumab dose escalation in patients with Crohn's disease
Scientific Title	Effect of adalimumab dose escalation in patients with Crohn's disease
Scientific Title:Acronym	Effect of adalimumab dose escalation in patients with Crohn's disease
Region	Japan

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

Objectives
Narrative objectives1	To reveal the factors affecting effectiveness of adalimumab dose escalation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationships between adalimumab trough levels before dose escalation and clinical remission rate at 12 weeks or mucosal healing in 24 weeks
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	99 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who are treated with 40mg of adalimumab biweekly 2. CDAI more than 150, massive intestinal lesion, or refractory perianal disease 3. Patients who do not correspond to the warning or contraindication of the package insert of adalimumab 4. Dose escalation of adalimumab is possible under health insurance 5. Aged 15 and over
Key exclusion criteria	1. Patients without intestinal mucosal lesion 2. Patients with active tuberculosis 3. Patients with demyelinating disease 4. Patients with chronic heart failure 5. Serum creatinine more than 2 mg/dl 6. Total bilirubin more than 2 mg/dl 7. AST or ALT more than 50 IU/l 8. Patients under pregnancy or breast-feeding 9. Patients who wishes to become pregnant 10. Less than 15 years old 11. Patients who has neoplasm 12. Patients who have psychoneurotic disorder 13. Patients who do not agree to join this study 14. When the doctor in charge feel that the patients are not suitable for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shigeki Middle name Last name Bamba
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Zip code	520-2192
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Email	hqmed2@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Shigeki Middle name Last name Bamba
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Zip code	520-2192
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Homepage URL
Email	sb@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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	Shiga Unniversity of Medical Science
Address	Seta-Tsukinowa, Otsu
Tel	077-548-2217
Email	sb@belle.shiga-med.ac.jp

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 08 Month 22 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	0
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 08 Month 05 Day
Date of IRB	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 08 Month 23 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2016 Year 08 Month 22 Day
Last modified on	2020 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027324