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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022104
Receipt No. R000025482
Scientific Title Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Date of disclosure of the study information 2016/04/27
Last modified on 2019/02/28

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Basic information
Public title Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Acronym Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Scientific Title Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Scientific Title:Acronym Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical usefulness of fecal calprotectin (FC) as a biomarker to predict the outcome of Adalimumab (ADA) in Ulcerative Colitis (UC) patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Study design for predicting outcomes:
Evaluation of sensitivity, specificity of FC by comparing the remission rate at week 52 between patients with a decreased FC at 12 week and other patients who have been treated with ADA for 52 weeks.

* Patients with a decreased FC at 12 week: Patients whose values of FC at 12w were <320 microgram/gram and their reduction rates were over 30% comparing to their FC values before ADA induction.

2. Study design for recurrence prediction:
Comparison the value of FC in ADA inducting UC patients (over 12w) between patients who relapsed during following period (minimal following period: 9 month) and patients who did not.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Study design for predicting outcomes: Steroid dependent or moderate to severe UC patients who are decided to include ADA.

2. Study design for recurrence prediction: UC patients who have been treated with ADA as a maintenance therapy for over 12 week.

3. Patients are able to provide written informed consent after having received adequate explanation on the purpose of the study and the nature of the procedures involved.
*In under age cases (below 20 years) consent from one of the patient's parents will be obtained.

4. Patients aged 16 years or older.

Key exclusion criteria 1. Pregnant woman

*Patients who become pregnant during study period to be required to discontinue the study

2. Patients unable to provide informed consent.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamura MD. PhD.
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
TEL 0798-45-6663
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takako Miyazaki MD. PhD.
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
TEL 0798-45-6663
Homepage URL
Email takako35@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
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 04 Month 27 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 Terminated
Date of protocol fixation
2016 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 01 Month 07 Day

Other
Other related information This study has been terminated.

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025482

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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