UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis
Title of the study (Brief title)	Tocilizumab mono-therapy for microscopic polyangiitis
Region	Japan

Condition
Condition	Microscopic polyangiitis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of tocilizumab monotherapy for microscopic polyangiitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Improvement of major clinical signs and symptoms at week 24. (MPO-ANCA or PR3-ANCA, serum CRP and ESR, BVAS2003, VDI)
Key secondary outcomes	Improvement of major clinical signs and symptoms at week 52 Exacerbation of major clinical signs and symptoms at week 104

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	tocilizumab monotherapy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who fulfilled the 2007 Watts algorithm. 1) Watts R et al. Development and validation of a consensus methodology for the classification of theANCA-associated vasculitides and polyarteritis nodosa for epidemiological studies. Ann Rheum Dis. 2007 Feb; 66(2): 222-7.
Key exclusion criteria	1) patients who are prohibited to use tocilizumab by the JCR guideline for proper tocilizumab use 2) patients who are thought to be inappropriate for the treatment with tocilizumab by their attending doctor
Target sample size	10

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	0492283859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Ryota Sakai
Organization	Saitama Medical Center, Saitama Medical Universitity
Division name	Department of Rheumatology & Clinical Immunology
Address	1981 Kamoda Kawagoe, Saitama 350-8550
TEL	0492283574
Homepage URL
Email	r_sakai@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology
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 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2015 Year 10 Month 30 Day
Date of closure to data entry	2015 Year 10 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 22 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=R000013175