NCT01517620

Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Total Glucosides Paeony Capsules	Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-01-25
• Last updated: 2013-12-13

Locations

2 sites across 1 country: China