臨床研究等提出・公開システム

Date of registration	Jan. 29, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080222730

Scientific Title	Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis
Public Title	Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis

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	Eisai Co., Ltd
	Address	https://www.eisai.co.jp/inquiry/product/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		2000
Study Type		Observational
Study Design	Study Design	Open label, Post-marketing surveillance
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with rheumatoid arthritis All patients who take iguratimod
	Exclusion Criteria	Pregnant women or women suspected of being pregnant Patients with a serious liver disorder Patients with peptic ulcer Patients with known hypersensitivity to iguratimod or any of its excipients Patients receiving treatment with warfarin
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Rheumatoid Arthritis
Intervention(s)		investigational material(s) Generic name etc : Kolbet INN of investigational material : Iguratimod Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy DAS28
Secondary Outcome

Primary Sponsor	Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.)
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	-
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-152782
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 24, 2018	Detail	Changes
5	Oct. 24, 2018	Detail	Changes
4	Feb. 13, 2018	Detail	Changes
3	July. 11, 2017	Detail	Changes
2	Jan. 29, 2015	Detail	Changes
1	Jan. 29, 2015	Detail

List of change history