A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis — SELECT-AXIS 1  

Ankylosing Spondylitis (AS) Clinical Trial

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Clinical Trial Description

This study includes two periods: a 14-week double-blind placebo-controlled period and a 90-week open-label long-term extension period.

Eligible participants were randomly assigned in a 1:1 ratio to receive upadacitinib 15 mg or placebo for 14 weeks in Period 1.

Participants who completed Period 1 received upadacitinib 15 mg for 90 weeks in the extension period. ;

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

• NCT number: NCT03178487
• Study type: Interventional
• Source: AbbVie
• Status: Completed
• Phase: Phase 2
• Start date: October 24, 2017
• Completion date: February 17, 2022