A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease - Full Text View

A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00445432

Purpose

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Condition	Intervention	Phase
Crohn's Disease	Biological: adalimumab Biological: Placebo	Phase II Phase III

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease

Drug Information available for:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official 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

Further study details as provided by Abbott:

Primary Outcome Measures:

Crohn's Disease Activity Index (CDAI) [ Time Frame: Until approval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Until Approval ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab 40 mg eow: Experimental	Biological: adalimumab 40 mg eow, sc
Placebo: Placebo Comparator	Biological: Placebo eow, sc

Eligibility

Ages Eligible for Study:	15 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445432

Locations


Japan

	Hokkaido, Japan

	Miyagi, Japan

	Chiba, Japan

	Tokyo, Japan

	Kanagawa, Japan

	Shizuoka, Japan

	Aichi, Japan

	Shiga, Japan

	Kyoto, Japan

	Okinawa, Japan

	Hyogo, Japan

	Okayama, Japan

	Hiroshima, Japan

	Kagawa, Japan

	Ehime, Japan

	Kochi, Japan

	Fukuoka, Japan

	Osaka, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators


Study Director:	Morio Ozawa	Abbott Japan Co.,Ltd

More Information

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M06-837
First Received:	March 7, 2007
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00445432
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Crohn Disease

Inflammatory Bowel Diseases

Adalimumab

Gastroenteritis

Intestinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008