Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- the proportion of patients which disease activity reaches relapse criteria
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Total Glucosides Paeony, Capsules
干预措施: Total Glucosides Paeony Capsules (Drug)
结局指标
主要结局
the proportion of patients which disease activity reaches relapse criteria
时间窗: 24 weeks
次要结局
- BASDAI score comparing to baseline(24 weeks)
- BASFI score comparing to baseline(24 weeks)
研究者
Gu Jieruo
Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University