UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)
Title of the study (Brief title)	Treatment of LVV and PMR by tocilizumab mono-therapy
Region	Japan

Condition
Condition	Rheumatoid arthritis
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 LVV and PMR
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	mprovement of major clinical signs and symptoms at week 12(fever,abnormal findings of temporal artery, myalgia, serum CRP, ESR, abnormal radiological findings of the affected vessels)
Key secondary outcomes	Improvement of major clinical signs at week 52, relapse rate and adverse events during 52 weeks

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	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who fulfilled the 1990 ACR classification criteria for giant cell arteritis and Takayasu arteritis and the 2012 EULAR/ACR provisional classification criteria for PMR 1) Bloch DA, et al.: The ACR 1990 criteria for the classification of vasculitis. Patients and methods. Arthritis Rheum 1990; 33:1068-1073 2) Dasgupta B, et al.: 2012 Provisional classification criteria for polymyalgia rheumatica: a EULAR/ACR collaborative initiative. Arthritis Rheum 2012; 64: 943-954
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	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	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	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)

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	2012 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 30 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010359