UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012469 |
|---|---|
| Receipt number | 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 | 2024/03/31 23:50:37 |
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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
kenjiw1779@gmail.com
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
kenjiw1779@gmail.com
Sponsor or person
Institute
Castle Study Group
Institute
Department
Personal name
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
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
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014594
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| Registered date | File name |
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