UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026558 |
|---|---|
| Receipt number | R000030482 |
| Scientific Title | A multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2019/09/18 16:53:30 |
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Basic information
Public title
A multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study
Acronym
A multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study
Scientific Title
A multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study
Scientific Title:Acronym
A multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluating the safety and efficacy of biologic treatments in patients with rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Secular changes in patient characteristics at initiation of biologics
2) Retention rate of biologic treatments
3) Efficacy and retention rate of methotrexate treatment
Key secondary outcomes
1) Predictors of discontinuation of biologic and methotrexate treatments
2) Correlation between efficacy of biologic and methotrexate treatments
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) Patients who receive or will receive biologics for rheumatoid arthritis
Key exclusion criteria
1) Patients who receive or have received biologics for any disease other than rheumatoid arthritis
2) Patients judged as inadequate at the discretion of physicians
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | TOSHIHISA |
| Middle name | |
| Last name | Kojima |
Organization
Nagoya University Hospital
Division name
Orthopedic Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-1908
toshik@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Asai |
Organization
Nagoya University Hospital
Division name
Orthopedic Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-1908
Homepage URL
asai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (Kakenhi)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Nagoya University Hospital
Address
65 Tsurumai, Showa, Nagoya, Japan
Tel
052-741-2111
ethics@med.nagoya-u.ac.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
名古屋医療センター（愛知県） 安城更生病院（愛知県） JCHO東京新宿メディカルセンター（東京都） 名古屋セントラル病院（愛知県） 豊橋市民病院（愛知県） 豊田厚生病院（愛知県） 長野赤十字病院（長野県） 江南厚生病院（愛知県） 刈谷豊田総合病院（愛知県） 一宮市立市民病院（愛知県） 静岡厚生病院（静岡県） 中東遠総合病院（静岡県） 名古屋第一赤十字病院（愛知県） 名古屋エキサイカイ病院（愛知県） 半田市立半田病院（愛知県） かとう整形外科（愛知県） 伊藤整形外科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2008 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2008 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030482
