臨床研究等提出・公開システム

Date of registration	June. 07, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221821

Scientific Title	A Phase I study of rontalizumab
Public Title	A Phase I study of rontalizumab

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

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

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

Recruitment Status

Date of First Enrolment
Target Sample Size		21
Study Type		Interventional
Study Design	Study Design	Randomized, placebo-controlled study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Diagnosis of SLE based on meeting at least 4 of 11 of the 1997 American College of Rheumatology (ACR) classification criteria prior to informed consent and duration of SLE of >/= 12 months. (2)For patients with reproductive potential (males and females), able to use a reliable means of contraception (3)For female patients, uterine cervical cytology results of cytology class II or below confirmed on uterine cervical cancer testing.
	Exclusion Criteria	(1)Received >20 mg/day or 0.5 mg/kg/day (body weights <40 kg) prednisolone equivalent corticosteroids for >/= 4 days within 30 days prior to informed consent (2)Received any of the drug below or transfusions within three months prior to informed consent - pulse dose corticosteroids, - azathioprine, - mizoribine, - methotrexate, - mycophenolate mofetil, - cyclosporine, - tacrolimus, - sirolimus, - monoclonal antibody - intravenous immunoglobulin (IVIG) (3)Received cyclophosphamide within two years prior to informed consent (4)Previously received another study drug directed against IFNalpha (5)History of B-cell depleting therapy or anti-BLYS therapy within 12 months prior to informed consent
	Minimum Age	20age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Systemic lupus erythematosus (SLE)
Intervention(s)		investigational material(s) Generic name etc : Rontalizumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Single and multiple subcutaneous administration of 3 different doses of rontalizumab
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety, Pharmacokinetics Observation, Laboratory tests
Secondary Outcome		NA NA

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	NA

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
Date of Approval by IRB

Secondary ID No.	JapicCTI-121864
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Feb. 23, 2015	Detail	Changes
7	Feb. 23, 2015	Detail	Changes
6	May. 20, 2013	Detail	Changes
5	May. 20, 2013	Detail	Changes
4	Oct. 01, 2012	Detail	Changes
3	Oct. 01, 2012	Detail	Changes
2	June. 07, 2012	Detail	Changes
1	June. 07, 2012	Detail

List of change history