UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparison of effectiveness between intravenous and subcutaneous administration route of tocilizumab in patients with rheumatoid arthritis
Title of the study (Brief title)	The comparison of effectiveness between intravenous and subcutaneous administration route of tocilizumab in patients with rheumatoid arthritis
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness by using ultrasonography between intravenous and subcutaneous administration route of tocilizumab in patients with rheumatoid arthritis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The comparison of ultrasonographic findings between intravenus and subcutaneous administration route of tocilizumab
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	RA patients fulling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010. The patients started tocilizumab therapy.
Key exclusion criteria	Patients with other diseases that can affect the infllamation state. Patients who was deemed inappropriate by test doctor to participate in this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Tadashi Okano
Organization	Osaka City University Medical School
Division name	Orthopedic Surgery
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	0666453851
Email	ma1sa3ru@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tadashi Okano
Organization	Osaka City University Medical School
Division name	Orthopedic Surgery
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	0666453851
Homepage URL
Email	ma1sa3ru@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Medical School
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The comparison of ultrasonographic findings between intravenus and subcutaneous administration route of tocilizumab

Management information
Registered date	2017 Year 07 Month 17 Day
Last modified on	2017 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032339