UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028343 |
|---|---|
| Receipt number | R000032440 |
| Scientific Title | Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations- |
| Date of disclosure of the study information | 2017/07/23 |
| Last modified on | 2020/01/27 08:48:45 |
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Basic information
Public title
Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Acronym
Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Scientific Title
Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Scientific Title:Acronym
Current Status of the Effectiveness of Infliximab with Crohn's disease-A prospective observational study of serum Infliximab consentrations-
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively study treatment outcomes in Crohn's disease patients who received infliximab, including measurement of serum infliximab concentrations and the titers of antibodies to infliximab for 2 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement rates 54 weeks after starting treatment with infliximab
Key secondary outcomes
remission and improvement rates 14, 54 and 102 weeks after starting treatment with infliximab
serum infliximab concentrations and ATI rates at these times
correlations of serum infliximab concentrations with disease severity and the treatment response
The rate of continuing treatment with infliximab
side effect
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Crohn's disease active stage in Kitasato University Hospital
over 16 years old
Key exclusion criteria
Patients enrolled in other clinical trial
pregnancy
past history: cancer, malignancy
serious infection
tuberculosis
allergy to medicine
multiple sclerosis
heart fairuler
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yokoyama |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL
042-778-8111
kaoru.y@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yokoyama |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL
042-778-8111
Homepage URL
kaoru.y@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
1-15-1 Kitasato Minami, Sagamihara Kanagawa
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
Tel
042-778-8111
rinri@med.kitasato-u.ac.jp
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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 23 | 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
12
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 | 10 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Crohn's disease cases who need Infliximab that adapted to criteria for selection
case registration period: From 27 Dec 2013 to 31 Dec 2016.
measurement items:complete blood count, clinical chemistry tests,serum infliximab concentrations, ATI
Management information
Registered date
| 2017 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032440
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
