臨床研究等提出・公開システム

Date of registration	Dec. 01, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221322

Scientific Title	Phase IIa study of T-5224 in RA patients
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	FUJIFILM Toyama Chemical Co., Ltd.
	Address	https://www.fujifilm.co.jp/form/fftc/en/general/input.php?id=FFTCClinicalEn
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Double blind, randomized and multi center study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Male or female. -Subject who have a diagnosis of Rheumatoid Arthritis by the ACR criteria. -Age greater or 20 years and less than 65 years old. -Subject who diagnosed to class 1-3 of Steinblocker dysfunction classification.
	Exclusion Criteria	-Subject with autoimmune disease except RA and SS. -Subject who is pregnancy, has possibility of pregnancy, hopes for pregnancy, is suckling.
	Minimum Age	20age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Rheumatoid Arthritis
Intervention(s)		investigational material(s) Generic name etc : T-5224 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety
Secondary Outcome		Efficacy and safety

Primary Sponsor	Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical 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
Date of Approval by IRB

Secondary ID No.	JapicCTI-101359
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Oct. 02, 2018	Detail	Changes
9	Oct. 02, 2018	Detail	Changes
8	Jan. 10, 2013	Detail	Changes
7	Jan. 10, 2013	Detail	Changes
6	Feb. 08, 2012	Detail	Changes
5	Feb. 08, 2012	Detail	Changes
4	Mar. 17, 2011	Detail	Changes
3	Mar. 17, 2011	Detail	Changes
2	Dec. 01, 2010	Detail	Changes
1	Dec. 01, 2010	Detail

List of change history