UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010524 |
|---|---|
| Receipt number | R000012305 |
| Scientific Title | Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy |
| Date of disclosure of the study information | 2013/04/17 |
| Last modified on | 2016/04/18 07:29:51 |
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Basic information
Public title
Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease
-OASISstudy
Acronym
Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease
-OASISstudy
Scientific Title
Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease
-OASISstudy
Scientific Title:Acronym
Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease
-OASISstudy
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the usefulness and safety of switching to adalimubab when it is combined with azathioprine to treat Crohn's disease patients responding poorly to infliximab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Interventions/Control_2
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.
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
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.
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Nagahori |
Organization
Tokyo Medical & Dental University
Division name
Gastroenterology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5877
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Nagahori |
Organization
Tokyo Medical & Dental University
Division name
Gastroenterology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5877
Homepage URL
nagahori.gast@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical & Dental University Gastroenterology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 17 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012305
