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

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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 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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name