A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis - Full Text View

Purpose

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

Condition	Intervention	Phase
Ankylosing Spondylitis	Biological: adalimumab	Phase III

Genetics Home Reference related topics:

ankylosing spondylitis

MedlinePlus related topics:

Ankylosing Spondylitis

ChemIDplus related topics:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

Further study details as provided by Abbott:

Primary Outcome Measures:

Assessment in Ankylosing Spondylitis 20 (ASAS 20) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ASAS 50 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS 70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Evaluation of adverse event, vital sign and laboratory tests [ Time Frame: During study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab: Experimental	Biological: adalimumab 40 mg every other week, subcutaneous

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs

Exclusion Criteria:

History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
Previously received anti-TNF therapy
Spinal surgery or joint surgery involving to be assessed within 2 months prior to the Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667355

Contacts


Contact: Abbott Japan Clinical Trials Registration Desk		abtj-ctr@abbott.com

Locations


Japan
		Recruiting
	Hokkaido, Japan
		Recruiting
	Nagano, Japan
		Recruiting
	Saitama, Japan
		Recruiting
	Tokyo, Japan
		Recruiting
	Kanagawa, Japan
		Recruiting
	Aichi, Japan
		Recruiting
	Toyama, Japan
		Recruiting
	Fukuoka, Japan
		Recruiting
	Shiga, Japan
		Recruiting
	Osaka, Japan
		Recruiting
	Hyogo, Japan
		Recruiting
	Hiroshima, Japan
		Recruiting
	Kagawa, Japan
		Recruiting
	Fukui, Japan

Sponsors and Collaborators

Abbott

Eisai Limited

Abbott Japan Co.,Ltd

Investigators


Study Director:	Shigeki Hashimoto, Ph.D.	Abbott

More Information

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M10-239
First Received:	April 24, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00667355
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Ankylosing Spondylitis

Study placed in the following topic categories:

Spinal Diseases

Musculoskeletal Diseases

Spondylarthropathy

Arthritis

Joint Diseases

Spondylitis, Ankylosing

Adalimumab

Spondylarthritis

Bone Diseases

Spondylitis

Ankylosis

Spondylarthropathies

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Antirheumatic Agents

Infection

Pharmacologic Actions

Bone Diseases, Infectious

ClinicalTrials.gov processed this record on August 20, 2008

Sponsors and Collaborators:	Abbott Eisai Limited Abbott Japan Co.,Ltd
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00667355