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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012072
Receipt No. R000014111
Scientific Title A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis
Date of disclosure of the study information 2013/12/01
Last modified on 2015/10/19

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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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