UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022727 |
|---|---|
| Receipt number | R000026178 |
| Scientific Title | Investigation of method for prediction of therapeutic effect of adalimumab initial therapy for inflammatory bowel disease |
| Date of disclosure of the study information | 2016/06/14 |
| Last modified on | 2016/06/13 23:07:57 |
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Basic information
Public title
Investigation of method for prediction of therapeutic effect of adalimumab initial therapy for inflammatory bowel disease
Acronym
IPADIN study
Scientific Title
Investigation of method for prediction of therapeutic effect of adalimumab initial therapy for inflammatory bowel disease
Scientific Title:Acronym
IPADIN study
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have investigated whether trough level of Adalimumab predicts future outcomes of induction therapy.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point was prediction of a clinical response at 6 months.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with IBD who admitted to ofuna chuo hospital for induction therapy of Adalimumab.
Patients who gave written informed consent for this study
Key exclusion criteria
Patients who are considered not suitable for Adalimumab use due to contraindication or considerable risks such as hypersensitivity to Adalimumab.
Other than above mentioned criteria, patients who are judged inappropriate by the doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Yoshida |
Organization
Ofuna Chuo Hospital
Division name
Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
Address
Ofuna 6-2-24, Kamakura, Japan
TEL
+81-46-745-2111
atushi.y@kza.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Yoshida |
Organization
Ofuna Chuo Hospital
Division name
Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
Address
Ofuna 6-2-24, Kamakura, Japan
TEL
+81-46-745-2111
Homepage URL
atushi.y@kza.biglobe.ne.jp
Sponsor or person
Institute
Ofuna Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 06 | Month | 14 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have investigated whether trough level of Adalimumab predicts future outcomes of induction therapy using PK/PD model.
Management information
Registered date
| 2016 | Year | 06 | Month | 13 | Day |
Last modified on
| 2016 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
