CTRI/2011/05/001734已完成3 期
Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis: A Double Blind, Randomized Comparison with Methotrexate alone
Ipca Laboratories Ltd Mumbai0 个研究点目标入组 77 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female subjects in the age range of 4 to 16 years (both inclusive).
- •-Subjects who have a diagnosis of JRA according to the ACR (American College of Rheumatology) criteria for JRA.
- •-Active pauciarticular (i.e. inflammation in fewer than 5 joints) or polyarticular JRA (i.e. equal to or greater than 5 swollen joint or equal to or greater than 3 joint with limitation of movement accompanied by either pain on motion or tenderness or both which could be of the same joint and rheumatoid factor positive or negative) without systemic onset that persists for at least 6 weeks and inadequately controlled by NSAIDs plus any DMARDs.
- •-Ready to give consent/assesnt
排除标准
- •-Subjects having active systemic course of JRA(i.e. persistent intermittent fever with or without erythematosus rash, hepatosplenomegally , lymphadenopathy , serositis or other organ involvement)
- •-Current inflammatory diseases or history of diseases other than juvenile rheumatoid arthritis (like lupus erythematosus, vasculitis, dermatomyositis, scleroderma, rheumatic fever, anterior uveitis, fibromyalgia, SLE infectious arthritis, psoriasis or ankylosing spondylitis, sacroiliitis with inflammatory bowel disease).
- •-Subjects who had undergone joint surgery within the preceding two months of the screening visit
研究者
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