UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for effectiveness and safety of tocilizumab therapy in rheumatoid arthritis patients with renal insufficiency.
Title of the study (Brief title)	Tocilizumab for rheumatoid arthritis patients with renal insufficiency
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effctiveness and safey of tocilizumab therapy in treating rheumatoid arthritis patients with renal insufficiency
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes in CDAI values after the 24-week treatment with tocilizumab
Key secondary outcomes	Improvement of anemia after the 24-week treatment with tocilizumab

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	All patients with rheumatoid arthritis who were treated with tocilizumab in participating hospitals.
Key exclusion criteria	None
Target sample size	400

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

Public contact
Name of contact person	Shinji Furukawa
Organization	NHO Kumamoto Saishunsou National Hospital
Division name	Secretariat
Address	2659 Suya, Kohshi, Kumamoto, Japan
TEL	81-96-242-1000
Homepage URL
Email	8211sy01@hosp.go.jp

Sponsor
Institute	NHO Kumamoto Saishunsou National Hospital
Institute
Department

Funding Source
Organization	NHO Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Sasebo Chuo Hospital Shimin-no-Mori Hospital Yoshitama Clinic for Rheumatic Diseases
Name of secondary funｄer(s)	Chugai Pharmaceutical Co.

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	国立病院機構熊本再春荘病院（熊本県）、佐世保中央病院（長崎県）、市民の森病院（宮崎県）、吉玉リウマチ科内科（鹿児島県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 25 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2015 Year 09 Month 29 Day
Date of closure to data entry	2015 Year 09 Month 29 Day
Date trial data considered complete	2015 Year 09 Month 29 Day
Date analysis concluded	2015 Year 09 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Main outcome measures CDAI and Hb Secondary measures Severe adverse effect Base line Characteristis Age, Sex, RA stage, RA class, ACPA, RF, Height, Body weight, serum Cr, Previous biologics, Concomitant used drugs, Hypertention, NIDDM

Management information
Registered date	2014 Year 08 Month 24 Day
Last modified on	2017 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017249