Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in disease activity scale
研究概览
简要总结
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
详细描述
In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with RA, as defined by the American College of Rheumatology (ACR) 1987 revised criteria or ACR/EULAR 2010,
- •Severly Active RA by calculating either DAS28 or SDAI or CDAI.
- •Patient selected are those who started etanercept for less than 3months and still active.
排除标准
- •Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this study. or methotrexate (MTX)..
- •Patients with hypersensitivity or severe adverse effects to niclosamide .
- •Renal impairment.
- •Hepatic impairment.
- •Pregnancy or a desire to become pregnant.
- •Breast feeding.
- •Patients with Juvenile RA [16 years old or younger].
- •Patients using other conventional disease modifying antirheumatic drugs (DMARDs).
- •Patients on steroid.
- •Patients with coexistence other connective tissue diseases or hypothyroid disease.
- •Patient with mild or inactive RA.
研究组 & 干预措施
Placebo and etanercept
Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
干预措施: Placebo (Drug)
Placebo and etanercept
Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
干预措施: Etanercept (Drug)
Niclosamide and etanercept
Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks
干预措施: Niclosamide (Drug)
Niclosamide and etanercept
Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks
干预措施: Etanercept (Drug)
结局指标
主要结局
Change in disease activity scale
时间窗: Day 1
Mean change of disease activity index from baseline using clinical disease activity index (CDAI).
次要结局
- The Change in disease activity scale(24 hours to 48 hours day)
- Change in disease activity score(Day 2)
- disease activity change scale(Day 3)
- safety of niclosamide(Day 1)
研究者
Faiq Gorial
consultant
University of Baghdad