Unique ID issued by UMIN | UMIN000016640 |
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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 |
Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Loss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
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.
Efficacy
Exploratory
Pragmatic
Not applicable
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.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Nobuyuki Hida MD. PhD. |
Hyogo College of Medicine
Department of Inflammatory Bowel Disease, Division of Internal Medicine
1-1, Mukogawa, Nishinomiya, Hyogo, ZIP code: 6638501
0798-45-6663
hidan@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takako Miyazaki MD. PhD. |
Hyogo College of Medicine
Department of Inflammatory Bowel Disease, Division of Internal Medicine
1-1, Mukogawa, Nishinomiya, Hyogo, ZIP code: 6638501
0798-45-6663
takako35@hyo-med.ac.jp
Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Self funding
Japan
NO
2015 | Year | 02 | Month | 26 | Day |
Partially published
Completed
2014 | Year | 07 | Month | 09 | Day |
2014 | Year | 08 | Month | 01 | Day |
2019 | Year | 01 | Month | 29 | Day |
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.
2015 | Year | 02 | Month | 25 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019313
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