UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010856 |
|---|---|
| Receipt number | R000012708 |
| Scientific Title | Predictors of long-term remission in patients with Crohn's disease treated with adalimumab |
| Date of disclosure of the study information | 2013/06/03 |
| Last modified on | 2014/12/31 12:55:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Predictors of long-term remission in patients with Crohn's disease treated with adalimumab
Acronym
Predictors of long-term remission in CD treated with ADA
Scientific Title
Predictors of long-term remission in patients with Crohn's disease treated with adalimumab
Scientific Title:Acronym
Predictors of long-term remission in CD treated with ADA
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous studies demonstrated the ability of adalimumab to induce and maintain remission in patients with Crohn's disease. However, little is known about predictive factors of long-term remission. Therefore, this study was designed to determine the predictors of long-term remission in patients with Crohn's disease treated with adalimumab and to develop a more safety and efficacious therapeutic strategy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical remission rates (evaluated by CDAI) at 52 weeks of adalimumab treatment.
Key secondary outcomes
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with active Crohn's disease (CDAI>150) refractory to the conventional therapies
Key exclusion criteria
(1) Contraindication for adalimumab
(2) Previous use of adalimumab
(3) Less than 15 years old
(4) Women who are pregnant or breastfeeding
(5) Less than 6 months after surgery
(6) Patients with short bowel syndrome
(7) Patients with malignancy
(8) Patients who are considered unsuitable in the opinion of the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Katsuno |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Gastroenterology and Nephrology (K1)
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi 260-8670, Japan
TEL
043-222-7171
katsuno@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuro Katsuno |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Gastroenterology and Nephrology (K1)
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi 260-8670, Japan
TEL
043-222-7171
Homepage URL
katsuno@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University, Department of Gastroenterology and Nephrology (K1)
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Chiba University, Department of Gastroenterology and Nephrology (K1)
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
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
| 2013 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CDAI, serum CRP, fecal calprotectin, fecal lactoferrin and adverse events will be measured or estimated at week 0, 8, 24 and 52 or just after cessation of adalimumab.
Lemann score will be estimated at week 0 and 52 or just after cessation of adalimumab.
Management information
Registered date
| 2013 | Year | 06 | Month | 02 | Day |
Last modified on
| 2014 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
