UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis
Acronym	Tocilizumab with corticosteroids in microscopic polyangiitis
Scientific Title	A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis
Scientific Title:Acronym	Tocilizumab with corticosteroids in 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 with corticosteroids for microscopic polyangiitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

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. Relapse rate 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 group
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 tocilizumab by their attending doctor
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Zip code
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	0492283859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryota Sakai
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Zip code
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	0492283574
Homepage URL
Email	r_sakai@saitama-med.ac.jp

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

Funding Source
Organization	Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 18 Day
Last modified on	2015 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014111

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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