NCT01114880

Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Detailed description

Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab	Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
OTHER	placebo	Prefilled syringe, matching placebo administered subcutaneously every other week

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2011-02-01
• First posted: 2010-05-03
• Last updated: 2011-12-01
• Results posted: 2011-11-04

Locations

9 sites across 1 country: China