UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021492 |
|---|---|
| Receipt number | R000024788 |
| Scientific Title | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. |
| Date of disclosure of the study information | 2016/03/20 |
| Last modified on | 2018/09/10 12:08:13 |
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Basic information
Public title
To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Acronym
Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific Title
To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific Title:Acronym
Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in safety and efficacy before and after switch prescripution.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
rheumatoid arthritis treated infliximab
Key exclusion criteria
1.Patients who corresponds to a contraindication of infliximab of infliximab biosimilar 1
2.Patients their doctors find not appropriate for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Inoue |
Organization
Inoue Hospital
Division name
Dpepartment of Rheumatology
Zip code
Address
55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan
TEL
027-322-3660
m2inoue@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Inoue |
Organization
Inoue Hospital
Division name
Dpepartment of Rheumatology
Zip code
Address
55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan
TEL
027-322-3660
Homepage URL
m2inoue@marianna-u.ac.jp
Sponsor or person
Institute
Inoue Hospital
Institute
Department
Personal name
Funding Source
Organization
Inoue Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024788
