UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013078 |
|---|---|
| Receipt number | R000015264 |
| Scientific Title | Tight control for the anti- TNF alpha antibody- treated CD (Crohn's disease) patients with thiopurine intensification determined by the capsule endoscopic appearances of small intestinal rejoins |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/01/02 22:08:48 |
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Basic information
Public title
Tight control for the anti- TNF alpha antibody- treated CD (Crohn's disease) patients with thiopurine intensification determined by the capsule endoscopic appearances of small intestinal rejoins
Acronym
Tactics study
Scientific Title
Tight control for the anti- TNF alpha antibody- treated CD (Crohn's disease) patients with thiopurine intensification determined by the capsule endoscopic appearances of small intestinal rejoins
Scientific Title:Acronym
Tactics study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of thiopuirine derivatives to anti-TNF alpha antibody- treated CD patients with small intesitinal involvements evaluated by capsule endoscopiy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement ratio of small intestinal regions evaluated by CECDAI at 6 months
Key secondary outcomes
mucosal healing rates of small intestinal regions at 6 months
serum CRP titer at 6 months
serum anti-TNF alpha concentration at 6 months
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
thiopurine derivatives
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
anti-TNF alpha antibody treated CD patients without steroids whose CDAI titer is below 150
patients with informed consents
Key exclusion criteria
patients refractory with infliximab and adalimumab
patients refractory with thiopurine derivatives
patients whose WBC titer is under 3000/mm3
pregnant patients
patients in the lactation
patients has past history of malignancy
patients who in not suitable to this study determined by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo kato |
Organization
Saitama Medical Center
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
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 Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center
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
| 2014 | Year | 03 | 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
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2014 | Year | 02 | Month | 05 | 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=R000015264
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
