A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

This study is ongoing, but not recruiting participants.

First Received: April 24, 2008 Last Updated: October 8, 2009 History of Changes

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Adalimumab

U.S. FDA Resources

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 ]

Enrollment:	41
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

Locations

Japan, Metropolis

Tokyo, Metropolis, Japan
Japan, Prefecture

Hokkaido, Prefecture, Japan

Nagano, Prefecture, Japan

Saitama, Prefecture, Japan

Kanagawa, Prefecture, Japan

Aichi, Prefecture, Japan

Toyama, Prefecture, Japan

Fukuoka, Prefecture, Japan

Shiga, Prefecture, Japan

Osaka, Prefecture, Japan

Hyogo, Prefecture, Japan

Hiroshima, Prefecture, Japan

Kagawa, Prefecture, Japan

Fukui, Prefecture, Japan

Sponsors and Collaborators

Abbott

Eisai Limited

Abbott Japan Co.,Ltd

Investigators

Study Director:

Hideyuki Hashiba

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M10-239
Study First Received:	April 24, 2008
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00667355 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Ankylosing Spondylitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Spinal Diseases
Joint Diseases
Infection
Adalimumab
Bone Diseases
Pharmacologic Actions
Bone Diseases, Infectious
Musculoskeletal Diseases

Therapeutic Uses
Arthritis
Spondylitis, Ankylosing
Antirheumatic Agents
Spondylarthritis
Spondylitis
Spondylarthropathies
Ankylosis

ClinicalTrials.gov processed this record on November 09, 2009