UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016340 |
|---|---|
| Receipt number | 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 09:47:28 |
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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
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
Hiroko.yamazaki@capimedi.com
Sponsor or person
Institute
NORTHERN CAPITAL CLINIC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018958
