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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: 2 April 2019
Main ID:  JPRN-UMIN000010524
Date of registration: 17/04/2013
Prospective Registration: No
Primary sponsor: Tokyo Medical & Dental University Gastroenterology
Public title: Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy
Scientific title:
Date of first enrolment: 2013/03/29
Target sample size: 20
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012305
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Masakazu Nagahori   
Address:  1-5-45, Yushima, Bunkyo-ku, Tokyo Japan
Telephone: 03-5803-5877
Email:
Affiliation:  Tokyo Medical & Dental University Gastroenterology
Name: Masakazu Nagahori   
Address:  1-5-45, Yushima, Bunkyo-ku, Tokyo Japan
Telephone: 03-5803-5877
Email: nagahori.gast@tmd.ac.jp
Affiliation:  Tokyo Medical & Dental University Gastroenterology
Key inclusion & exclusion criteria
Inclusion criteria: Patients with active Crohn's disease (CDA I of at least 150) on infliximab treatment (5-10 mg/kg/4-8 weeks), but without a history of adalimubab use.
Exclusion criteria: (1)Adalimumab contraindication
1)Patients with severe infection (Sepsis, etc)
2)Patients with active tuberculosis
3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab
4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease
5)Patients with congestive heart failure
(2)Azathioprine contraindication
1)Patients with history of hypersensitivity to any of the other ingredients of Azathioprine
2)Patients with the number of leukocytes below 3000/mm3
3)Pregnant or likely to be pregnant women
(3)Lactating women
(4)Patients < 15 years of age
(5)Patients not approving the study consent
(6)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate within 8 weeks.
(7)Patients with malignancy
(8)Patients in 3 months after gastrointestinal surgery
(9)Patients with short bowel syndrome or an artificial anus
(10)Patient has an imminent CD-related surgery
(11)Patients judged as inadequate at the discretion of physicians


Age minimum: 15years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.
Primary Outcome(s)
Amount of change in CDI from baseline to 24 hr post-treatment by status of azathioprine concomitant use.
Plasma adalimubab concentration at 24 weeks by status of azathioprine concomitant use.
Secondary Outcome(s)
CDAI and remission achievement rate at each evaluation time by status of azathioprine concomitant use. (Remission:below CDAI150)
AAA positive rate at 24 weeks by status of azathioprine concomitant use
Changes in endoscopic findings(SES-CD) before and at 24 weeks of treatment by status of azathioprine concomitant use
CRP at each evaluation time by status of azathioprine concomitant use
AAA positive rate at 24 weeks by status of ATI before treatment
Remission achievement rate at each evaluation time by status of ATI
Adverse events etc.
Secondary ID(s)
Source(s) of Monetary Support
none
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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