UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy
Title of the study (Brief title)	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity
Region	Japan

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

Objectives
Narrative objectives1	To investigate the remission or low disease activity of tocilizumab therapy in RA patients with moderate disease activity under biologic therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Low disease activity rate at 24 weeks (SDAI)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients between 20 and 75 years old 2)Patients with rheumatoid arthritis 3)Patients with low to moderate activity activity under more than 24 weeks of anti-tumour necrosis factor biologic therapy 4)Moderate disease activity by SDAI 5)The patient by whom consent is got in written form about participation of the final examination
Key exclusion criteria	1)Patients who have serious infection 2)Patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies 3)Patients who have history of a malignant tumor, or who have malignant tumor 4)Patients who have serious cardiac disease or liver disease, renal damage 5)Pregnant women or women trying to get pregnant 6)Patients considered inappropriate judged by attending physicians
Target sample size	20

Research contact person
Name of lead principal investigator	Daihei Kida
Organization	Nagoya Medical Center, National Hospital Organization in Japan
Division name	Department of Orthopaedic Surgery and Rheumatology
Address	4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan
TEL
Email

Public contact
Name of contact person
Organization	Nagoya Medical Center, National Hospital Organization in Japan
Division name	Department of Orthopaedic Surgery and Rheumatology
Address	4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Daihei Kida
Institute
Department

Funding Source
Organization	Nagoya Medical Center, National Hospital Organization in Japan
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 02 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 28 Day
Anticipated trial start date	2013 Year 02 Month 14 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

Management information
Registered date	2013 Year 02 Month 14 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011736