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

NCT01517620 Phase 4 COMPLETED

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 4
Status	COMPLETED
Enrolment	38
Start date	2011-11
Completion	2012-11

Conditions

• Ankylosing Spondylitis

Interventions

• Total Glucosides Paeony Capsules

Primary outcomes

• the proportion of patients which disease activity reaches relapse criteria — 24 weeks

Countries

China