NCT00667355

A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab	40 mg or 80 mg every other week, subcutaneous

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-05-01
• Completion: 2011-01-01
• First posted: 2008-04-28
• Last updated: 2012-01-26
• Results posted: 2010-08-11

Locations

19 sites across 1 country: Japan