臨床研究等提出・公開システム

Date of registration	Nov. 07, 2017
Last modified on	Jan. 12, 2021
Trial ID	jRCT2080223704

Scientific Title	A PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS
Public Title	Tocilizumab LTE study in patients with SSc

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		Nov. 10, 2017
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	Open-label, Single-arm study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who participated in WA29767 study and finished assessments scheduled at Week 96
	Exclusion Criteria	(1) Evidence of moderately severe pulmonary (e.g., asthma and emphysema), cardiovascular, hepatic, nervous system, renal, endocrine, or gastrointestinal disease not related to SSc as determined by the investigator at study entry (2) Known active current bacterial, viral, fungal, mycobacterial, or other recurrent infections (e.g., atopical mycobacterial disease, hepatitis B or C, herpes zoster, infected digital ulcers, and osteomyelitis) at study entry
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Systemic sclerosis
Intervention(s)		investigational material(s) Generic name etc : tocilizumab INN of investigational material : tocilizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : 162 mg/week, SC control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy pharmacodynamics Safety: adverse event, laboratory value, vital sign Efficacy: change in mRSS, FVC, J-HAQ Pharmacodynamics: change in PD biomarker concentration (IL-6, sIL-6R, CRP, ESR)
Secondary Outcome		-

Primary Sponsor	CHUGAI PHARMACEUTICAL CO., LTD
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Sept. 12, 2017

Secondary ID No.	JapicCTI-173760
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Jan. 12, 2021	(this page)	Changes
4	Dec. 26, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Nov. 07, 2017	Detail	Changes
1	Nov. 07, 2017	Detail

List of change history