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

Sponsors and Collaborators:	Abbott 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

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Adalimumab

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

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

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
Study First Received:	April 24, 2008
Last Updated:	January 12, 2009
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 January 16, 2009