UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027465 |
|---|---|
| Receipt number | R000031466 |
| Scientific Title | Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis |
| Date of disclosure of the study information | 2017/05/24 |
| Last modified on | 2018/05/23 13:03:11 |
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Basic information
Public title
Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
Acronym
Efficacy and safety of IFX-BS in UC patients
Scientific Title
Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
Scientific Title:Acronym
Efficacy and safety of IFX-BS in UC patients
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show the efficacy and safety of biosimilar Infliximab in the patients with ulcerative colitis in the remission state by the maintenance therapy of Infliximab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar
Key secondary outcomes
The value of partial Mayo's score
The value of serum CRP
The value of serum albumin
The value of hemoglobin
The increase of Infliximab or biosimilar Infliximab
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infliximab (5mg/kg, every 8 weeks, for 12 months)
Interventions/Control_2
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with ulcerative colitis treated with Infliximab
2) Being in the clinical remission state (partial Mayo's score <2, and CRP < 0.5mg/dl)
Key exclusion criteria
1) Patients younger than 20 years old
2) Patients keeping in the clinical remission state for more than 10 years
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohachi Nanjo |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code
Address
Sugitani 2630, Toyama City, Toyama Prefecture, Japan
TEL
076-434-7301
snanjo@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohachi Nanjo |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc
Zip code
Address
Sugitani 2630, Toyama City, Toyama Prefecture, Japan
TEL
076-434-7301
Homepage URL
snanjo@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
plural commercial corporations
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031466
