UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005761 |
|---|---|
| Receipt number | R000006811 |
| Scientific Title | The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2018/12/19 10:28:09 |
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Basic information
Public title
The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab
Acronym
The Efficacy of Adalimumab
Scientific Title
The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab
Scientific Title:Acronym
The Efficacy of Adalimumab
Region
| Japan |
Condition
Condition
Crohn's Disease patient as following 1)or 2)
1)the patient who treated with IFX infusion of interval every 4-6 weeks.
2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety about Adalimumab(ADA) for the patient who treated with IFX infusion of interval every 4-6 weeks or who could not keep to treat with IFX due to side effect or ineffectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adalimumab (HUMIRA 40mg for SC Injection)
Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Crohn's Disease patient as following 1)or 2)
1)the patient who treated with IFX infusion of interval every 4-6 weeks.
2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.
Key exclusion criteria
1)The patient of contraindication for adalimumab as following
a.serious infections
b.active tuberculosis
c.hypersensitivity
d.neurologic reactions (peripheral demyelinating disease)
e.congestive heart failure
2)The case which is hard to get the patient's consent
3)The patient who was judged for unsuitable by responsibility doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Watanabe |
Organization
Osaka City University Gradatescool of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Gradatescool of Medicine
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
nkamata@med.osaka-cu.ac.jp
Sponsor or person
Institute
Kenji Watanabe
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006811
