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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012469
Receipt No. R000014594
Scientific Title Comparison of Adalimumab and Steroid in Intestinal Behcet's disease
Date of disclosure of the study information 2013/12/02
Last modified on 2020/03/01

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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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