臨床研究等提出・公開システム

Date of registration	Aug. 30, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221906

Scientific Title	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
Public Title

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
	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	antinuclear antibodies (ANA) positive patients age 18 or older with active SLE without active lupus nephritis or active central nervous system (CNS) involvement
	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 240mg loading dose followed by 120 mg every 4 weeks and LY2127399 240mg loading dose followed by120 mg every 2 weeks for 52 weeks
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-121951
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 21, 2016	Detail	Changes
5	Oct. 21, 2016	Detail	Changes
4	July. 31, 2013	Detail	Changes
3	July. 31, 2013	Detail	Changes
2	Sept. 11, 2012	Detail	Changes
1	Aug. 30, 2012	Detail

List of change history