Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in JADAS-27 score from baseline to week 24
研究概览
简要总结
A randomized control trial open level and parallel design was conducted in the department of paediatrics, Bangladesh Medical University (BMU). All diagnosed cases of Refractory Polyarticular JIA according to ILAR criteria, unresponsive to MTX were enrolled in this study. After getting written informed consent from the parents/legal guardians, a detailed structured data collection sheet was used for data collection. After enrollment all participants were allocated into experimental group and control group by randomization using random allocation software version 2.0. Total sample size of this study is 50 and 25 participants in each group. All patients of experimental group were given leflunomide along with existing MTX in refractory polyarticular JIA patients and injectable MTX were given at standard dose(15mg/m² BSA) Considering high disease activity steroid were continued in both group at low bridging dose 0.05-1 mg/kg/dose. Patient's disease activity status was assessed by JADAS-27 at initial visit, 6th weeks, 12 weeks and 24 weeks. Functional impairment was assessed by CHAQ-B (DI) at baseline and 24th weeks of treatment. Statistical analysis of the collected data were carried out by using an appropriate statistical tool.
详细描述
Study design:
Randomized control trial, Open level, Parallel design
Place of study:
Department of Pediatric Rheumatology Division (OPD clinic and Inpatient), Department of Paediatrics, Bangladesh Medical University
Study period:
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
- 1 Day 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All diagnosed cases of Refractory Polyarticular Juvenile Idiopathic Arthritis (JIA) according to ILAR, 2001 unresponsive to methotrexate (at standard dose of 15mg/m² body surface area at least 3-6 months) as monotherapy or together with low dose steroid as bridge therapy who attended Paediatric Rheumatology Division (OPD clinic and inpatient), Department of Paediatrics of BMU, during the study period.
排除标准
- •1. A patient with prior or current infectious disorders, including active/latent tuberculosis, and/or H/O chronic or recurrent severe infections, including opportunistic infections.
- •2. A patient with leucopenia (White blood cell count < 3000/mm3), neutropenia (Neutrophil count < 1000/mm3) and thrombocytopenia (Platelet count < 100000/mm3).
- •3. Serum creatinine > upper limit of normal reference range.
- •Alanine aminotransaminase (ALT) more than 2 times of upper normal limit.
- •All diagnosed cases of refractory polyarticular JIA who did not give the consent during the study period.
研究组 & 干预措施
Leflunomide plus Methotrexate (Experimental group)
Experimental group
干预措施: Leflunomide plus Methotrexate (Drug)
Methotrexate Monotherapy (Control Group)
Control group
干预措施: Methotrexate Monotherapy (Drug)
结局指标
主要结局
Change in JADAS-27 score from baseline to week 24
时间窗: 24 weeks
The mean change in Juvenile Arthritis Disease Activity Score-27 (range 0-57) from baseline to week 24. Higher scores indicate greater disease activity
次要结局
- Proportion achieving inactive disease (JADAS ≤1)(24 weeks)
- Proportion achieving low disease activity(24 weeks)
- Mean change in JADAS-27 variables(24 weeks)
- Incidence of adverse events(24 weeks)
- Change in improvement of functional impairment by CHAQ-B(DI)(24 weeks)
研究者
Md Mahbubur Rahman
Dr. Md. Mahbubur Rahman
Bangladesh Medical University