NCT02201043

Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis. 2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Thalidomide 150mg
DRUG	Thalidomide 100mg
DRUG	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-07-25
• Last updated: 2015-11-20

Locations

9 sites across 1 country: China