Response of Methotrexate Alone Versus Methotrexate Combined With Etanercept for Achieving Minimal/Low Disease Activity in Patients of Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA
研究概览
简要总结
This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months . In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Injection Etanercept+ Tab methotrexate).
Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded
详细描述
Juvenile Idiopathic Arthritis (JIA) is the primary form of inflammatory arthritis observed in children. JIA is characterized by inflammation of the synovial tissue, which is present in joints, around tendons. The treatment approach for JIA depends on the specific subtype and severity of the disease. It involves the use of various medications, including non-steroidal anti-inflammatory drugs (NSAIDs), oral and intra-articular corticosteroids, as well as both biologic and nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months after approval. In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Tab methotrexate Monotherapy).
Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded on a performa. Data will be analyzed through SPSS version 26. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. chi-square test will be used to estimate the association between qualitative variables. A p-value<0.05 will be significant. The primary goal of this study is to reduce the duration of active arthritis, improve the quality of life for both patients and their parents, and minimize the risk of irreversible osteoarthritic changes
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
盲法说明
This is an open label study, No masking both the participants and the investigators, including care providers and outcome assessors, are aware of the treatment assignments.
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Polyarticular JIA patients aged 2-16years Male or female patients Newly diagnosed patients
排除标准
- •Other type of JIA including systemic-onset JIA, psoriatic arthritis, enthesitis-related arthritis, and oligoarticular arthritis Chronic or acute infection or severe infection episodes that required hospitalization or intravenous administration of antibiotics 30 days prior to study initiation A previous history of malignancy Active tuberculosis or any opportunistic infection, including herpes zoster Hepatitis B Positive patients A history of any chronic disease (except for JIA) that could influence the effectiveness or safety of the investigational medicinal product in investigator's opinion
研究组 & 干预措施
Group A
Group A Includes those patients who fulfills inclusive criteria and given Tablet methotrexate 10-15mg/m2/week orally along with Injection Etanercept 0.8mg/kg/week subcutaneously.
干预措施: Injection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered) (Drug)
Group B
Group B Includes those patients who fulfills inclusive criteria and given Tablet methotrexate 10-15mg/m2/week orally alone
干预措施: Injection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered) (Drug)
结局指标
主要结局
Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA
时间窗: 24 weeks
Proportion of patients achieving minimal/Low disease activity based on JDAS-10 between 0.8 t0 3.9 in Polyarticular Juvenile Idiopathic Arthritis.
次要结局
未报告次要终点
研究者
Dr Faisal Haneef
Post Graduate Trainee
University of Child Health Sciences and Children's Hospital, Lahore