|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000024566 |
|
Date of registration:
|
01/11/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.
|
|
Scientific title:
|
Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. - Study on the selection of appropriate patients for the dose escalation of adalimumab. |
|
Date of first enrolment:
|
2016/11/01 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027990 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Yasuo Suzuki |
|
Address:
|
564-1 Shimoshizu, Sakura, Chiba, Japan
Japan |
|
Telephone:
|
043-462-8811 |
|
Email:
|
yasuo-suzuki@sakura.med.toho-u.ac.jp |
|
Affiliation:
|
Toho University Medical Center Sakura Hospital Department of Internal Medicine |
|
|
Name:
|
Yasuo Suzuki |
|
Address:
|
564-1 Shimoshizu, Sakura, Chiba, Japan
Japan |
|
Telephone:
|
043-462-8811 |
|
Email:
|
yasuo-suzuki@sakura.med.toho-u.ac.jp |
|
Affiliation:
|
Toho University Medical Center Sakura Hospital Department of Internal Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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
Age minimum:
16years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn'disease
|
|
Intervention(s)
|
Dose escalation group Administration of Adalimumab 80 mg every other week
Non-dose escalation group Administration of Adalimumab 40 mg every other week
|
|
Primary Outcome(s)
|
|
Comparison of clinical remission rates at 1 year after randomization between dose escalation group and non-dose escalation group.
|
|
Secondary Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
None
|
|
Ethics review
|
Status: YES
Approval date: 19/08/2016
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/12/2016 |
|
URL:
|
|
|
|