UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032633 |
|---|---|
| Receipt number | R000037197 |
| Scientific Title | Study for efficacy and safety of switching treatment from ENBREL to etanercept biosimilar |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2020/11/30 13:32:12 |
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Basic information
Public title
Study for efficacy and safety of switching treatment from ENBREL to etanercept biosimilar
Acronym
Observational study for registration data of switching to etanercept biosimilar
Scientific Title
Study for efficacy and safety of switching treatment from ENBREL to etanercept biosimilar
Scientific Title:Acronym
Observational study for registration data of switching to etanercept biosimilar
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety for RA patients switching from ENBREL to etanercept BS on daily medical examination in Japan
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
DAS-28-CRP at week 12
Key secondary outcomes
DAS28-CRP at week 24 and week 52
ESR at week12, week 24 and week52
each components of DAS28 at week21, week 24 and week 52
DAS28-CRP for recurrence of RA patients
compatibility after switcning BS
variation at week12
adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Rheumatoid arthritis patients
2.RA activity maintained low disease or remmison over 12 weeks treated with ENBREL
3.informed consent for treatment with etanrcept BS
Key exclusion criteria
RA activity not maintained low disease treateted with ENBREL
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Matsubara |
Organization
Matsubara mayflower Hospital
Division name
Rheumatology
Zip code
673-1462
Address
944-24, Fujita, Kato, Hyogo, Japan , 673-1462
TEL
0795-42-8851
mats@mayflower-hp.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Funahashi |
Organization
Matsubara Mayflower Hospital
Division name
Pharmacy
Zip code
673-1462
Address
944-24, Fujita, Kato, Hyogo, Japan , 673-1462
TEL
0795-42-8851
Homepage URL
http://www.mayflower-hp.jp
k-funahashi@mayflower-hp.jp
Sponsor or person
Institute
Matsubara Mayflower Hospital
Institute
Department
Personal name
Funding Source
Organization
Ayumi pharamceutical Corporation
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
Ethics Committee of Matsubara Mayflower Hospital
Address
944-25, Fujita, Kato, Hyogo, 673-1462
Tel
0795-42-8851
tiken@mayflower-hp.jp
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
片山整形外科リウマチ科（北海道）、佐川昭リウマチクリニック（北海道）、泉原リウマチ・内科クリニック（鹿児島県）、みつかリウマチクリニック（千葉県）、橋本整形外科リウマチクリニック（兵庫県）、松原クリニック（兵庫県）、吉田整形外科・リウマチ科、近藤リウマチ・整形外科クリニック、東仙台リウマチ科内科クリニック、三宅整形医院、吉井病院、織部リウマチ科内科クリニック、草薙整形外科リウマチクリニック、松原メイフラワー病院、豊見城中央病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
subjet are RA patients switching to etanercept BS, therefore to analysis for pycholigical factor and RA activity
Management information
Registered date
| 2018 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037197
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
