UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk of Hospitalized Bacterial Infections associated with Biologics Treatmentfor Rheumatoid Arthritis Patients: A real registry study.
Title of the study (Brief title)	Safety of biologics treatment for rheumatoid arthritis patients
Region	Japan

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

Objectives
Narrative objectives1	Investigate the risk of hspitalized bacterial infections associated with biologics treatment for rheumatoid arthritis patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hosiptalized bacterial ingections
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Rheumatoid arthritis patients who first treated with biologics between 2009 Jan 1 and 2014 Dec 31.
Key exclusion criteria	None
Target sample size	1500

Research contact person
Name of lead principal investigator	Shunsuke Mori
Organization	National Hospital Organization, Kumamoto Saishunsou National Hospital
Division name	Center for Rheumatic Disease
Address	2659 Suya Kohshi, Kumamoto, Japan
TEL	81-96-242-1000
Email	moris@saisyunsou1.hosp.go.jp

Public contact
Name of contact person	Shunsuke Mori
Organization	National Hospital Organization, Kumamoto Saishunsou National Hospital
Division name	Center for Rheumatic Disease
Address	2659 Suya Kohshi, Kumamoto, Japan
TEL	81-96-242-1000
Homepage URL
Email	moris@saisyunsou1.hosp.go.jp

Sponsor
Institute	National Hospital Organization, Kumamoto Saishunsou National Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization, Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	佐世保中央病院、NHO九州医療センター、NHO福岡病院、市民の森病院、吉玉クリニック、大分赤十字病院、横浜南共済病院、諫早総合病院、長崎大学公衆衛生学教室、埼玉医科大学国際尾量センター、近畿中央病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 30 Day
Anticipated trial start date	2014 Year 04 Month 30 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry	2015 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 07 Month 01 Day
Date analysis concluded	2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Analysis: Cox hazard analysis Risk factor Age, Sex, RA class & stage, smoking history, cormobideity (NIDDM, chronic renal disease), Chest CT findings(pulmonary emphysema or interstitial pneumonia or airway disease), concurrent PSL, concurrent MTX

Management information
Registered date	2015 Year 02 Month 02 Day
Last modified on	2017 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019059