UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035185 |
|---|---|
| Receipt number | R000040100 |
| Scientific Title | The study of the combination effect of granulocyte/monocyte adsorptive apheresis in Crohn's disease patients who lose response to Infliximab therapy |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2023/12/12 13:33:47 |
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Basic information
Public title
The study of the combination effect of granulocyte/monocyte adsorptive apheresis in Crohn's disease patients who lose response to Infliximab therapy
Acronym
The study of the combination effect of GMA in Crohn's disease patients who lose response to Infliximab therapy
Scientific Title
The study of the combination effect of granulocyte/monocyte adsorptive apheresis in Crohn's disease patients who lose response to Infliximab therapy
Scientific Title:Acronym
The study of the combination effect of GMA in Crohn's disease patients who lose response to Infliximab therapy
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Granulocyte/ Monocyte Adsorption apheresis (GMA) for Crohn's disease patients who lose response to infliximab therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of clinical response (improvement of CDAI score more than 70 points) at week 16
Key secondary outcomes
(1) Remission (CDAI<150) rate at week 16
(2) Change of blood lebel of IFX
(3) Change of antibody to infliximab(ATI)
(4) Change in CRP
(5) Safety assessment
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Crohn's disease patients with maintenance IFX therapy
(2) Patients with CDAI score of 220 to 450 points or serum CRP of more than 0.3mg/dl
(3) Patients considered being capable for venous catheter insertion
Key exclusion criteria
(1) Adacolumn contraindication
(2) Other patients judged as inappropriate by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Yokoyama |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of endoscopy
Zip code
951-8510
Address
1-754 Asahimachidori, Chuo-ku, niigata city
TEL
025-227-2207
yokoyaj@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Yokoyama |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of endoscopy
Zip code
951-8510
Address
1-754 Asahimachidori, Chuo-ku, niigata city
TEL
025-227-2207
Homepage URL
yokoyaj@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
none
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
Niigata University ethic screening committee
Address
1-754 Asahimachidori, Chuo-ku, niigata city
Tel
025-227-2625
https://niigata.bvits.com/rinri/
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
| 2019 | Year | 04 | Month | 01 | 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
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2018 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040100
