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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014006
Receipt No. R000016314
Scientific Title Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Date of disclosure of the study information 2014/07/31
Last modified on 2014/12/30

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Basic information
Public title Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Acronym Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific Title:Acronym Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab 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 The aims of this study are to assess the relation between efficacy and serum infliximab level, and to find predictors of response to infliximab dose escalation in patients with crohn's disease.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between CDAI change and serum infliximab level from week 0 to week 16 and 40 in increased dose period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dose escalation of infliximab
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with active crohn's disease ( CDAI>= 150 and CRP >= 0.3mg/dL ) on 5mg/kg infliximab
Key exclusion criteria 1)Patients whose age below 18 years old
2)Patients with serious infection (sepsis,etc)
3)Patients with active tuberculosis
4)Patients with history of allergy to ingredients of infliximab or to proteins derived from mouse
5)Patients with demyelinating diseases and its past history
6)Patients with congestive heart failure
7)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Motoya
Organization Sapporo Kosei General Hospital
Division name IBD Center
Zip code
Address Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL 011-261-5331
Email sa-motoya@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Tanaka
Organization Sapporo Kosei General Hospital
Division name IBD Center
Zip code
Address Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan
TEL 011-261-5331
Homepage URL
Email hirokit@mtc.biglobe.ne.jp

Sponsor
Institute IBD Center, Sapporo Kosei General Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Organization
Division
Category of Funding Organization
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
2014 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 20 Day
Last modified on
2014 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016314

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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