Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 5
- 主要终点
- Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)
研究概览
简要总结
Whether and when systemic lupus erythematosus (SLE) patients with stable disease should withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease more than one year and to establish a predictive model for flare risk stratification.
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) is used to be maintained in a low dose for a long time in fear of disease flare. Long-term GC could bring a lot of side-effects even in a low dose. Whether and when patients with stable disease should withdraw GC? How about the relapse risk? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of hydroxychloroquine in preventing SLE relapse. This study is an open-labeled randomized controlled clinical trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE diagnosis fulfilled the Systemic Lupus International Collaborating Clinic revision of the American College of Rheumatology Classification Criteria for SLE
- •Disease stabilized ≥ 1 year
- •SELENA-SLEDAI ≤ 3
- •Anti-double strand DNA negative by IF measurement and ≤ 200IU/ml by ELISA method
- •Complement 3 (C3) ≥ 0.5*lower limit of the normal range, and fluctuation of the C3 is less than 10% within the last year
- •24 hour urine protein ≤ 0.5g
- •Prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
- •No use of immunosuppressants including CsA, MMF, CTX, FK506, LEF, MTX in recent 6 months. But hydroxychloroquine (HCQ) is permitted and should be in use
- •Never use biologic agents including Rituximab, Belimumab, Epratuzumab and so on
- •No severe organ involvement in recent 2 years including lupus encephalosis, diffused alveolar hemorrhage, thrombotic thrombocytopenia purpura, rapid progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, myocardial involvement, myeleterosis or severe peripheral neuropathy
排除标准
- •Active SLE
- •In pregnancy or breastfeeding, plan for pregnancy
- •Plan or has been on a surgery in recent 6 months
- •Current infection
- •History of malignancy
- •Severe organ dysfunction or other complications
- •Unable to follow up
- •Inappropriate to be enrolled
- •Psoriasis, porphyria, arrhythmia or eye diseases that contradict with HCQ usage
研究组 & 干预措施
Full withdrawal
Intervention: 'Drug free'.
干预措施: Drug free (Other)
GC withdrawal
Intervention: 'HCQ' .
干预措施: HCQ (Drug)
No withdrawal
Intervention: 'GC+HCQ' .
干预措施: GC+HCQ (Drug)
结局指标
主要结局
Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI)
时间窗: 33 weeks
The SFI includes three elements: the SELENA-SLEDAI score (range 0 \~105, with 0 indicating inactive disease and ); an assessment of new or worsening disease activity, medication changes, and hospitalizations that not captured with the use of the SLEDAI; and the score on the physician's global-assessment (PGA) visual-analogue scale (range, 0 to 3, 1=mild, 2=moderate, 3=severe); Mild to moderate flare by SFI is defined as appearance of one of the following: a change in SLEDAI\>3 points but≤12 points; or new onset/worse of cutaneous/ mucosal injury (discoid, photosensitivity, profundus, cutaneous vasculitis, bullous lupus, Nasopharyngeal ulcers), serositis (pleuritis and/or pericarditis), arthritis, SLE associated fever; or the need to increase prednisone dosage to no more than 0.5 mg/kg/day; or the need to add hydroxychloroquine or NSAIDs with no increase in the dose GC; or an increment of PGA ranges from 1.0 to 2.5.
次要结局
- Percent of subjects with a SELENA-SLEDAI maintaining at <4 points(33 weeks)
- • Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system(33 weeks)
- Mean change in PGA(33 weeks)