UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Title of the study (Brief title)	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	Nobuyuki Hida MD. PhD.
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease, Division of Internal Medicine
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	Takako Miyazaki MD. PhD.
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease, Division of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019313