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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010524
Receipt No. 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

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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
Email

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
Email nagahori.gast@tmd.ac.jp

Sponsor
Institute Tokyo Medical & Dental University Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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