臨床研究等提出・公開システム

Date of registration	June. 10, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222103

Scientific Title	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
Public Title

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Parexel International
	Address	03-3537-5903
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Have completed 52 weeks of treatment in BCDS study
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		systemic lupus erythematosus (SLE)
Intervention(s)		investigational material(s) Generic name etc : LY2127399 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : LY2127399 given as a loading dose of 240 mg at Week 0, followed by 120 mg Q2W or 120 mg Q4W if participant received placebo in BCDS study.LY2127399 given as a loading dose of 120 mg at Week 0, followed by 120 mg Q2W or 120 mg Q4W if participant received LY2127399 in BCDS study.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Parexel International
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
Date of Approval by IRB

Secondary ID No.	JapicCTI-132149
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Oct. 21, 2016	Detail	Changes
3	Oct. 21, 2016	Detail	Changes
2	June. 10, 2013	Detail	Changes
1	June. 10, 2013	Detail

List of change history