UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016640
Receipt number 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 09:24:45

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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