UMIN-CTR Clinical Trial

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
Email	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
Email	asai@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030482