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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016340
Receipt No. R000018958
Scientific Title Comparison study for the best use of the biologic agent in rheumatoid arthritis treatment with certolizumab pegol in the real world
Date of disclosure of the study information 2015/02/16
Last modified on 2015/03/06

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Basic information
Public title Comparison study for the best use of the biologic agent in rheumatoid arthritis treatment with certolizumab pegol in the real world
Acronym Beagle study
Scientific Title Comparison study for the best use of the biologic agent in rheumatoid arthritis treatment with certolizumab pegol in the real world
Scientific Title:Acronym Beagle study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of initial loading of certolizumab pegol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary efficacy endpoint will be the percentage of subjects who achieve good response at 24W
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who treated with certolizumab pegol.
Key exclusion criteria Subjects who are inadequate for the treatment with certolizumab pegol according to the attached document of the drug must be excluded from participation in this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Munakata
Organization NORTHERN CAPITAL CLINIC
Division name Rheumatoid Arthritis
Zip code
Address AER16F,1-3-1,Cyuou, Aoba-ku,Sendai City,Miyagi
TEL 0227166251
Email munakata@munakata-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Yamazaki
Organization CAPITAL MEDICA CO,Ltd
Division name Clinical Trial Department
Zip code
Address 1-2-3,Toranomon,Minato-ku,Tokyo
TEL 0355012271
Homepage URL
Email Hiroko.yamazaki@capimedi.com

Sponsor
Institute NORTHERN CAPITAL CLINIC
Institute
Department

Funding Source
Organization NORTHERN CAPITAL CLINIC
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
Email

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
2015 Year 02 Month 16 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
2015 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information RA Patient

Management information
Registered date
2015 Year 01 Month 26 Day
Last modified on
2015 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018958

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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