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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023719
Receipt No. 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 2016/08/22

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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
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 077-548-2217
Email hqmed2@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 077-548-2217
Homepage URL
Email sb@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Address
Tel
Email

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
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
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 23 Day
Last follow-up date
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
2016 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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