UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014006 |
|---|---|
| Receipt number | R000016314 |
| Scientific Title | Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease |
| Date of disclosure of the study information | 2014/07/31 |
| Last modified on | 2022/10/03 13:39:02 |
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Basic information
Public title
Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Acronym
Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title
Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title:Acronym
Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to assess the relation between efficacy and serum infliximab level, and to find predictors of response to infliximab dose escalation in patients with crohn's disease.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between CDAI change and serum infliximab level from week 0 to week 16 and 40 in increased dose period
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dose escalation of infliximab
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with active crohn's disease ( CDAI>= 150 and CRP >= 0.3mg/dL ) on 5mg/kg infliximab
Key exclusion criteria
1)Patients whose age below 18 years old
2)Patients with serious infection (sepsis,etc)
3)Patients with active tuberculosis
4)Patients with history of allergy to ingredients of infliximab or to proteins derived from mouse
5)Patients with demyelinating diseases and its past history
6)Patients with congestive heart failure
7)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Motoya |
Organization
Sapporo Kosei General Hospital
Division name
IBD Center
Zip code
Address
Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL
011-261-5331
sa-motoya@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Tanaka |
Organization
Sapporo Kosei General Hospital
Division name
IBD Center
Zip code
Address
Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL
011-261-5331
Homepage URL
hirokit@mtc.biglobe.ne.jp
Sponsor or person
Institute
IBD Center, Sapporo Kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
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
| 2014 | Year | 07 | Month | 31 | 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
| 2014 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016314
