UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012790 |
|---|---|
| Receipt number | R000014942 |
| Scientific Title | Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/01/02 22:00:41 |
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Basic information
Public title
Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease
Acronym
CADELLAC study
Scientific Title
Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease
Scientific Title:Acronym
CADELLAC study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of infliximab dose intensification determined by capsule endoscopic evaluation of small intestinal involvements for 6 months steroid-free patients with CDAI acore whinch was no more than 150
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mucosal healing rates at 6 months
Key secondary outcomes
mucosal healing rates at 12 months
improvement of mucosal regions at 6 and 12 months
serum CRP titer at 6 and 12 months
stool calprotectin titer at 6 and 12 months
stool PTX3 titer at 6 and 12 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
dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months
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
6 months steroid free CD patients with CDAI which was no more than 150
Key exclusion criteria
patients with contraindication of infliximab
patients with pregnancy and lactation
patients without informed consent
patients under and after treatment of malignancy
Target sample size
20
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, 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
981 Kamoda, Kawagoe, 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 | 02 | 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 | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 08 | 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=R000014942
| 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 |
