臨床研究等提出・公開システム

Date of registration	Mar. 12, 2007
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220358

Scientific Title	A Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease
Public Title	A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease

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	Abbott Japan Co., Ltd.
	Address	E-mail: ABTJ-CTR@abbott.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		80
Study Type		Interventional
Study Design	Study Design	A Multi-Center, Randomized, Double-blind, Placebo-controlled Study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion criteria: - Subjects who successfully enrolled in and completed the M04-729 study Exclusion criteria: - Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
	Exclusion Criteria	Exclusion criteria: - Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
	Minimum Age	15age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Crohn's disease
Intervention(s)		investigational material(s) Generic name etc : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneous control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Subcutaneous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Crohn's Disease Activity Index (CDAI)
Secondary Outcome		IBDQ IOIBD SF-36

Primary Sponsor	Abbott Japan Co., Ltd.
Secondary Sponsor	Eisai Co., Ltd.

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-070367
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Aug. 15, 2011	Detail	Changes
5	Aug. 15, 2011	Detail	Changes
4	July. 01, 2010	Detail	Changes
3	June. 30, 2010	Detail	Changes
2	Mar. 12, 2007	Detail	Changes
1	Mar. 12, 2007	Detail

List of change history