UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024566 |
|---|---|
| Receipt number | R000027990 |
| Scientific Title | Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2021/07/19 17:03:05 |
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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
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
yasuo-suzuki@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Sakura Hospital
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027990
