UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006232 |
|---|---|
| Receipt number | R000007377 |
| Scientific Title | Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2018/01/02 21:41:55 |
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Basic information
Public title
Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab
Acronym
High dose infliximab with azathiopurine add-on therapy
Scientific Title
Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab
Scientific Title:Acronym
High dose infliximab with azathiopurine add-on therapy
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Additional effects of azathiopurine in the treatment of high dose infliximab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate in 24 week
Key secondary outcomes
Remission rates in each state
CR70, CR100
Mucosal healing rates in 24, 48 week
Loss of response rate
Relapse rate
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
Interventions/Control_2
treatment with only high dose infliximab
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had not been treated with immunomodulators and was not in remission state with low dose infliximab (CDAI<150)
Key exclusion criteria
patients who cannot been kept in the treatment with infliximab and who cannot been treated with azathiopurine
patients in lactate state
patient whose age below 15 years old and above 70 years old
patients who cannot agree with this study
patients who had been treated with open surgery within 6 months
patients with short bowel syndrome
patients who was determined not to be appropriate in participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
| 2011 | Year | 09 | 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
| 2011 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007377
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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