Efficacy and Safety of Hydroxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis: A Double Blind, Randomized Comparison with Methotrexate alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 9
- 主要终点
- Patients with a 30 percent improvement from baseline in at least 3 of the 6 following variables with no more than one of the remaining variables worsening by more than 30percent The core set are;
研究概览
简要总结
This is a double blind, randomized, parallel group, comparative, multicentric study of 24 weeks. This will be an outpatient study. The study will be initiated only after obtaining necessary approval from DCGI and hospitals ethics committees. At screening after successful fulfillment of informed consent and assent procedures, patients satisfying screening criteria have to undergo 7 days placebo washout period. At baseline visit, the patients satisfying all the entry criteria will be randomized 1:1 in two treatment arms for 24 weeks.During ht estudy patients will be evaluated for ACR Pedi 30 as a primary efficacy endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Patients with a 30 percent improvement from baseline in at least 3 of the 6 following variables with no more than one of the remaining variables worsening by more than 30percent The core set are;
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
1.Physician’s global assessment of disease activity
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
2.Parent’s/patient’s (if appropriate in age) global assessment of overall well-being
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
3.Functional ability by CHAQ Disability Index
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
4.Number of joints with active arthritis
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
5.Number of joints with limited range of motion; and
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
6.ESR.
时间窗: Week 0, 4,8,12,16,20 and 24 [Delete]
次要结局
- ACR Pedi 50, ACR Pedi 70, JAFAR-C, JAFAR-P(ACR Pedi 50, ACR Pedi 70: Week 0, 4,8,12,16,20 and 24)