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

Sun Yat-sen University38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Outcomes

Primary Outcomes

the proportion of patients which disease activity reaches relapse criteria

Time frame: 24 weeks

Secondary Outcomes

BASDAI score comparing to baseline

Time frame: 24 weeks

BASFI score comparing to baseline

Time frame: 24 weeks