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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Total Glucosides Paeony Capsules

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged from 16-65 years, sign the Informed Consent
• Fulfill 1984 modified NewYork classification criteria for AS
• Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
• Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
• Commitment to contraceptive for woman

Exclusion Criteria:

• History of psoriasis and/or inflammatory bowel diseases
• Receive intra-articular injection of cortisone within 3 months before enrollment
• History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
• Pregnant and lactating women
• Mentally ill, Alcoholics and drug addicts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no intervention
Experimental: Total Glucosides Paeony, Capsules	Drug: Total Glucosides Paeony Capsules; Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of patients which disease activity reaches relapse criteria	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
BASDAI score comparing to baseline	24 weeks
BASFI score comparing to baseline	24 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 15, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: [2011]2-38