臨床研究等提出・公開システム

Date of registration	Aug. 24, 2006
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220293

Scientific Title	Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis
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	Tanabe Pharma Corporation
	Address
	Phone Number
	E-mail Address	cti-inq-ml.JP@ml.tanabe-pharma.com

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	A multi-center, randomized, double-blind, parallel-group comparative clinical study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	[Inclusion criteria] Patients with active ulcerative colitis, who have failed to response, have failed to successfully taper or have medical complications to other existing medications, 16 years and above, male and female. [Exclusion criteria] Patients who have received infliximab in the past, have a history of serious infection which caused hospitalization within 6 months before the registration, have an active tuberculosis, have a complication or a history of malignancy within 5 years before the registration.
	Exclusion Criteria
	Minimum Age	16age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Ulcerative colitis
Intervention(s)		investigational material(s) Generic name etc : TA-650 (Infliximab) INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Intravenous drip infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy (clinical response), Safety and Pharmacokinetics
Secondary Outcome

Primary Sponsor	Tanabe Pharma Corporation
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-060298
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
15	Dec. 17, 2018	(this page)	Changes
14	Jan. 20, 2016	Detail	Changes
13	Jan. 20, 2016	Detail	Changes
12	Oct. 28, 2015	Detail	Changes
11	Oct. 28, 2015	Detail	Changes
10	Dec. 01, 2014	Detail	Changes
9	Dec. 01, 2014	Detail	Changes
8	June. 22, 2011	Detail	Changes
7	June. 22, 2011	Detail	Changes
6	June. 07, 2010	Detail	Changes
5	June. 07, 2010	Detail	Changes
4	Oct. 01, 2007	Detail	Changes
3	Oct. 01, 2007	Detail	Changes
2	Aug. 24, 2006	Detail	Changes
1	Aug. 24, 2006	Detail

List of change history