UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Adalimumab and Steroid in Intestinal Behcet's disease
Acronym	Castle Study
Scientific Title	Comparison of Adalimumab and Steroid in Intestinal Behcet's disease
Scientific Title:Acronym	Castle Study
Region	Japan

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

Objectives
Narrative objectives1	Comparison with adalimumab and steroid for the efficacy of remission induction in patients with intestinal Behcet's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endoscopic efficacy at 12 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously.
Interventions/Control_2	Oral administration of prednisolone with 0.6mg/kg/day during from 1 to 2 weeks, and tapering off until 12 weeks with decreasing dosage 5mg/kg/week approximately
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with intestinal Behcet's disease who were refractory to conventional treatment and contained with typical punched-out ulce in the cecum.
Key exclusion criteria	1) The patients with simple ulcer disease complicated without general Behcet's symptoms 2) Contraindication of adalimumab administration a: Severe infectious disease b: Active tuberculosis c: Past history for hypersensitivity of adalimumab contents d: Present or past history for demyelinating disorder e: Congestive heart failure 3) Contraindication for steroid administration a: Past history for hypersensitivity of prednisolone contents 4) Pregnant or breast feeding woman 5) Below the age of 15 years old 6) The patients who are unable to provide informed consent 7) The patients who are begun to administrate with more than 10mg/kg steroid within 2 weeks 8) The patients who are administrated with steroid more than 2 weeks 9) The patients who had been administrated with infliximab or adalimumab. However, the patients who were intolerant for infliximab within 2nd infusion (0 week or 2 weeks) can be enrolled. 10) The patients who are added or increased dosage of administration with as follows, 5-aminosalicylates or nutrition therapy within 2 weeks, colchicine or tacrolimus or ciclosporin or methotrexate within 4 weeks, azathioprine or 6-mercaptopurine within 8 weeks 11) Malignancy patient 12) The patients who are contained with untypical lesion for intestinal Behcet's disease 13) The patients who are indicated as insufficient by the physician
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Watanabe
Organization	Osaka City University
Division name	Department of Gastroenterology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-3811
Email	kenjiw@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Watanabe
Organization	Osaka City University
Division name	Department of Gastroenterology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-3811
Homepage URL
Email	kenjiw@med.osaka-cu.ac.jp

Sponsor
Institute	Castle Study Group
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	Osaka City University Hospital Certified Review Board
Address	1-2-7-601, Asahi-machi, Abeno-ku, Osaka
Tel	06-6645-3435
Email	ethics@med.osaka-cu.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	2013 Year 12 Month 02 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	Enrolling by invitation
Date of protocol fixation	2013 Year 10 Month 03 Day
Date of IRB	2013 Year 10 Month 03 Day
Anticipated trial start date	2013 Year 12 Month 02 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 02 Day
Last modified on	2020 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014594

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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