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 | 2025/06/01 21:01:54 |
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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
https://doi.org/10.1093/jpp/rgae092
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/jpp/rgae092
Number of participants that the trial has enrolled
11
Results
Data were obtained from 11 IBD patients. The therapeutic effect during maintenance therapy was successfully predicted at 40 of 47 time points. Moreover, the predicted effects at each patients final time point matched the observed effects in 9 of the 11 patients.
This is the inaugural report predicting the individual serum concentration and therapeutic effect of ADM using the Bayesian method and PK/PD modelling during the induction phase. This strategy may aid in optimizing ADM therapy for IBD.
Results date posted
| 2025 | Year | 06 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 15 | Day |
Baseline Characteristics
This was a prospective observational single-centre study. Active CD and UC patients who needed to receive ADM therapy from April 2016 to December 2017 were eligible for the study. These patients had not previously been administered ADM or had not received ADM for at least 12 weeks after the last administration. The study protocol was approved by the ethics committees of Tokyo University of Pharmacy and Life Sciences (approval number: 16-2) and Ofuna Chuo Hospital (approval number: 2016-5), and written informed consent was obtained from all patients. The study was conducted in accordance with the ethical standards of the national research committee and the Helsinki declaration.
Participant flow
A cohort study incorporating IBD (Inflammatory Bowel Disease) cases initiating adalimumab.
Adverse events
None
Outcome measures
Based on pharmacokinetic/pharmacodynamic (PK/PD) parameters calculated using the empirical Bayes method, we predicted individual serum concentrations of ADM and therapeutic effects during the induction phase.Then, we validated whether the predicted therapeutic effects (defined as clinical remission or treatment failure) matched the observed effects.
Plan to share IPD
No
IPD sharing Plan description
No
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 21 | Day |
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
| 2025 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026178
