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

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

October 8, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00667355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ankylosing Spondylitis

Intervention ^ICMJE

Biological: adalimumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00667355

Responsible Party

Eiichi Makino, Abbott

Study ID Numbers ^ICMJE

M10-239

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Eisai Limited
Abbott Japan Co.,Ltd

Investigators ^ICMJE

Study Director:

Hideyuki Hashiba

Abbott

Information Provided By

Abbott

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP