UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023719 |
|---|---|
| Receipt number | R000027324 |
| Scientific Title | Effect of adalimumab dose escalation in patients with Crohn's disease |
| Date of disclosure of the study information | 2016/08/22 |
| Last modified on | 2020/08/25 09:22:47 |
* 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
Effect of adalimumab dose escalation in patients with Crohn's disease
Acronym
Effect of adalimumab dose escalation in patients with Crohn's disease
Scientific Title
Effect of adalimumab dose escalation in patients with Crohn's disease
Scientific Title:Acronym
Effect of adalimumab dose escalation in patients with Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the factors affecting effectiveness of adalimumab dose escalation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationships between adalimumab trough levels before dose escalation and clinical remission rate at 12 weeks or mucosal healing in 24 weeks
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are treated with 40mg of adalimumab biweekly
2. CDAI more than 150, massive intestinal lesion, or refractory perianal disease
3. Patients who do not correspond to the warning or contraindication of the package insert of adalimumab
4. Dose escalation of adalimumab is possible under health insurance
5. Aged 15 and over
Key exclusion criteria
1. Patients without intestinal mucosal lesion
2. Patients with active tuberculosis
3. Patients with demyelinating disease
4. Patients with chronic heart failure
5. Serum creatinine more than 2 mg/dl
6. Total bilirubin more than 2 mg/dl
7. AST or ALT more than 50 IU/l
8. Patients under pregnancy or breast-feeding
9. Patients who wishes to become pregnant
10. Less than 15 years old
11. Patients who has neoplasm
12. Patients who have psychoneurotic disorder
13. Patients who do not agree to join this study
14. When the doctor in charge feel that the patients are not suitable for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga Unniversity of Medical Science
Address
Seta-Tsukinowa, Otsu
Tel
077-548-2217
sb@belle.shiga-med.ac.jp
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
| 2016 | Year | 08 | Month | 22 | 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
0
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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027324
