Unique ID issued by UMIN | UMIN000026330 |
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Receipt number | R000030245 |
Scientific Title | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease |
Date of disclosure of the study information | 2017/02/28 |
Last modified on | 2022/09/03 10:57:48 |
Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease
Efficacy and safety of IFX-BS in CD patients
Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease
Efficacy and safety of IFX-BS in CD patients
Japan |
Crohn disease
Gastroenterology |
Others
NO
To show the efficacy and safety of biosimilar Infliximab in the patients with Crohn disease in the remission state by the maintenance therapy of Infliximab.
Safety,Efficacy
The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar
The value of clinical disease activity index
The value of serum CRP
The value of serum albumin
The value of hemoglobin
The increase of Infliximab or biosimilar Infliximab
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with Crohn disease treated with Infliximab
2) Being in the clinical remission state (CDAI <150, and CRP < 0.5mg/dl)
1) Patients younger than 20 years old
2) Patients keeping in the clinical remission state for more than 10 years
30
1st name | Sohachi |
Middle name | |
Last name | Nanjo |
University of Toyama
Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences
930-0194
Sugitani 2630, Toyama City, Toyama Prefecture, Japan
076-434-7301
snanjo@med.u-toyama.ac.jp
1st name | Sohachi |
Middle name | |
Last name | Nanjo |
University of Toyama
Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc
930-0194
Sugitani 2630, Toyama City, Toyama Prefecture, Japan
076-434-7301
snanjo@med.u-toyama.ac.jp
University of Toyama
plural commercial corporations
Profit organization
Center for Clinical Research, Toyama University Hospital
Sugitani 2630, Toyama city, Toyama Prefecture, Japan
076-434-2281
yuka@adm.u-toyama.ac.jp
NO
2017 | Year | 02 | Month | 28 | Day |
Unpublished
18
Delay expected |
The delay of the data analysis
Completed
2017 | Year | 02 | Month | 27 | Day |
2017 | Year | 02 | Month | 27 | Day |
2017 | Year | 02 | Month | 27 | Day |
2018 | Year | 07 | Month | 30 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 31 | Day |
2017 | Year | 02 | Month | 28 | Day |
2022 | Year | 09 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030245
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