NCT01330901

Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

UsTekinumab for the Treatment Of Patients With Active Ankylosing Spondylitis (TOPAS) - a 28-week, Prospective, Open-label, Proof-of-concept Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal antibody against interleukin 12 and 23) treatment in patients with active ankylosing spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not tolerate or have a contraindication for NSAIDs.

Detailed description

This study is a prospective, open-label, proof-of-concept clinical trial that will be conducted in a referral center for patients with AS in Berlin. Eligible patients will be treated with ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16. The entire study period accounts 28 weeks. Assessment of the primary outcome parameter will be performed at week 24. The patients will be closely monitored throughout the study on a total of 9 visits.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Ustekinumab	Ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2011-04-07
• Last updated: 2013-06-04

Locations

1 site across 1 country: Germany