A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

NCT ID: NCT00667355

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-01-31

Brief Summary

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

Detailed Description

It is reported that the prevalence of Ankylosing Spondylitis (AS) in Japanese patients is extremely lower than that of Caucasians; therefore, a controlled, double-blind study with similar sample size in Western studies for active AS in Japan was not able to be conducted. As a result, this study was conducted with an open-label design to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active AS. The inclusion criteria and primary endpoint measurement (Achieving Assessment in Ankylosing Spondylitis 20 at Week 12) were designed the same as the Western studies for active AS in consideration with the confirmation of Western data. Treatment with adalimumab was to be continued until the approval of adalimumab for AS in Japanese subjects with active AS.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab

Adalimumab 40 mg or 80 mg subcutaneously (SC) administered every other week (eow) until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan. All subjects received 40 mg of adalimumab SC eow at Baseline. The subjects who completed 16 weeks of therapy and who failed to achieve Assessments in Ankylosing Spondylitis 20 (ASAS 20) response on or after Week 16, could increase the dose of adalimumab to 80 mg eow. When the dose was increased, the higher dose was to be continued during the rest of the study.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

40 mg or 80 mg every other week, subcutaneous

Interventions

adalimumab

40 mg or 80 mg every other week, subcutaneous

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira

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 joints to be assessed within 2 months prior to the Screening

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hideyuki Hashiba, BS

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference # / Investigator 46791

Aichi, , Japan

Site Reference # / Investigator 46789

Fukui, , Japan

Site Reference # / Investigator 46798

Fukuoka, , Japan

Site Reference # / Investigator 46799

Fukuoka, , Japan

Site Reference # / Investigator 46796

Hiroshima, , Japan

Site Reference # / Investigator 46782

Hokkaido, , Japan

Site Reference # / Investigator 7297

Hokkaido, , Japan

Site Reference # / Investigator 46795

Hyōgo, , Japan

Site Reference # / Investigator 46797

Kagawa, , Japan

Site Reference # / Investigator 46787

Kanagawa, , Japan

Site Reference # / Investigator 46790

Nagano, , Japan

Site Reference # / Investigator 46793

Osaka, , Japan

Site Reference # / Investigator 46794

Osaka, , Japan

Site Reference # / Investigator 46783

Saitama, , Japan

Site Reference # / Investigator 46784

Saitama, , Japan

Site Reference # / Investigator 46792

Shiga, , Japan

Site Reference # / Investigator 46785

Tokyo, , Japan

Site Reference # / Investigator 46786

Tokyo, , Japan

Site Reference # / Investigator 46788

Toyama, , Japan

Countries

Japan

Other Identifiers

M10-239

Identifier Type: -

Identifier Source: org_study_id