A randomized open label trial comparing the efficacy and safety of oral Prednisolone versus intravenous Methylprednisolone pulse therapy in Systemic Lupus Erythematosus.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical assessment
研究概览
简要总结
Baseline screening:
Informed consent will be taken
All demographic details like age, gender, and date of birth will be collected as per the data collection form.
General Medical History
Confirmation of the disease using ACR/EULAR criteria and measuring disease activity using SLEDAI-2K.
Monitoring the disease activity at every visit using SLAM-R and CLASI score.
Prior/Concomitant treatments
Complete physical examination and vital Signs: Blood pressure, pulse rate, and temperature
Laboratory testing: Complete Blood Count, Renal Function Tests, Liver Function Tests, Serum Electrolytes, Urine Analysis, 24-hour urine protein, Serology for HIV HBsAg HCV, ESR, CRP, ANA titre and ANA profile.
Follow up visits:
· After the screening, randomization, and treatment initiation (Week 0), Patients will return for assessments at Weeks 4, 8, 12, 16, 20, and 24.
· Collection of data as per data collection form.
· Complete physical examination and monitoring of adverse events at every visit.
· Calculation of SLAM R score and CLASI score at every visit.
· Lab investigations: Complete Blood Count, Renal Function Tests, Liver Function Tests, Urine Analysis at every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years and above with SLEDAI score more than 10 fulfilling the EULAR criteria.
排除标准
- •Patients on any treatment within last 3 months
- •Patients having features of other connective tissue diseases
- •Patients with other autoimmune conditions
- •Patients with pre-existing chronic renal failure, previous malignancy, and liver dysfunction, within six months prior to randomization.
- •Patients with previously documented severe toxicity to immunosuppressive drugs.
- •Pregnancy and lactation.
结局指标
主要结局
Clinical assessment
时间窗: At Week 4, 8, 12, 16, 20, and 24.
SLAM-R score
时间窗: At Week 4, 8, 12, 16, 20, and 24.
Routine investigations (Complete Blood count, Liver function tests, Renal function tests, Urine routine microscopy)
时间窗: At Week 4, 8, 12, 16, 20, and 24.
次要结局
- Adverse effects due to the drugs if any(At the end of 24 weeks)
研究者
Dr Asritha C V V
IMS and SUM Hospital