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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016640
Receipt No. R000019313
Scientific Title Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Date of disclosure of the study information 2015/02/26
Last modified on 2019/02/28

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Basic information
Public title Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Acronym Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Scientific Title Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Scientific Title:Acronym Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is an observational study of single center cohort to assess the therapeutic efficacy of infliximab (IFX) in consecutive patients with intractable ulcerative colitis (UC). Prospectively designed standardized follow-up schedule was used for the follow-up of patients by experienced clinicians in this study. The primary aim is to determine the proportion of UC patients with an initial response to IFX who lost sustainable clinical response to IFX during their maintenance therapy with IFX. Simultaneously, we determine serum IFX concentration and anti-IFX antibody (ATI) in the included UC patient's blood. In addition, we compare clinical findings, especially the status of mucosal healing between patients who lost response to IFX during maintenance therapy and those who continued to respond.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The percentage of intractable UC patients who lost response to IFX maintenance therapy.

Loss of response to IFX was defined as: patients who lost response to IFX during over 6 month maintenance therapy with scheduled every 8 weeks IFX following the initial response to IFX.
Key secondary outcomes Determination of serum IFX concentration and the ATI status in the included UC patients.

Comparison of endoscopic/ histological findings between patients who lost response to IFX maintenance therapy and patients who continued to respond.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who had been diagnosed with ulcerative colitis according to the diagnostic criteria defined by the research group of inflammatory bowel disease in the Ministry of Health, Labor and Welfare in Japan.
2) Ulcerative colitis patients who had been receiving scheduled IFX treatment for over 6 months.
3) Ulcerative colitis patients who had been assessed clinical/mucosal disease activity by experienced clinician before initial IFX administration.
4) Patients who were able to provide written informed consent before being included this study.
Key exclusion criteria 1) Patients who had not showed initial response to IFX before.

2) Patients who had been treated with IFX at short intervals (within 8 weeks) in their exacerbating period.

3) Patients who could not provide written informed consent before being included this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Hida 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, ZIP code: 6638501
TEL 0798-45-6663
Email hidan@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, ZIP code: 6638501
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 Japan

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
2015 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2014 Year 07 Month 09 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
2019 Year 01 Month 29 Day

Other
Other related information This is an observational study of single center cohort to assess the therapeutic efficacy of infliximab (IFX) in consecutive patients with intractable ulcerative colitis (UC). Prospectively designed standardized follow-up schedule was used for the follow-up of patients by experienced clinicians in this study. The primary aim is to determine the proportion of UC patients with an initial response to IFX who lost sustainable clinical response to IFX during their maintenance therapy with IFX. Simultaneously, we determine serum IFX concentration and anti-IFX antibody (ATI) in the included UC patient's blood. In addition, we compare clinical findings, especially the status of mucosal healing between patients who lost response to IFX during maintenance therapy and those who continued to respond.


Primary outcome is the percentage of intractable UC patients who lost response to IFX maintenance therapy.

Loss of response to IFX was defined as: patients who lost response to IFX during over 6 month maintenance therapy with scheduled every 8 weeks IFX following the initial response to IFX.

Secondly outcome: 1. Determination of serum IFX concentration and the ATI status in the included UC patients.

2. Comparison of endoscopic/ histological findings between patients who lost response to IFX maintenance therapy and patients who continued to respond.



Management information
Registered date
2015 Year 02 Month 25 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=R000019313

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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