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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032633
Receipt No. 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 2019/05/21

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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
Email mats@mayflower-hp.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Funahashi
Organization Matsubara Mayflower Hospital
Division name Clinical research
Zip code 673-1462
Address 944-24, Fujita, Kato, Hyogo, Japan , 673-1462
TEL 0795-42-8851
Homepage URL http://www.mayflower-hp.jp
Email tiken@mayflower-hp.jp

Sponsor
Institute Matsubara Mayflower Hospital
Institute
Department

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
Email 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 松野リウマチ整形外科(富山県)、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

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 Enrolling by invitation
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
2020 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 09 Month 30 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
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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