UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Maintenance of remission with 6-week interval of tocilizumab in RA patients who have been in remission
Title of the study (Brief title)	Maintenance of remission by 6-week tocilizumab in RA patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate the possibility of remission maintenance with 6-week interval of tocilizumab for RA patients who have been in remission with monthly tocilizumab therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	remission rate at 1 year after 6-week interval of tocilizumab therapy (DAS28-ESR &/or SDAI)
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	RA Patients who have been treated with tocilizumab for more than 6 months and have been in remisison for more than 3 months
Key exclusion criteria	Patients who have taken more than 5 mg/day of prednisolone
Target sample size	40

Research contact person
Name of lead principal investigator	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University Saitama Medical Center, Saitama Medical Univers
Division name	Department of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3859
Homepage URL
Email	amanokoi@saitama-med.ac.jp

Sponsor
Institute	Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity
Institute
Department

Funding Source
Organization	None
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	2014 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 12 Day
Anticipated trial start date	2013 Year 09 Month 12 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	Published
URL releasing results
Results	25 cases were enrolled
Other related information	Patients who do not agree to be enrolled to this study and continue monthly tocilizumab will be analyzed as the reference.

Management information
Registered date	2014 Year 10 Month 20 Day
Last modified on	2017 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017994