Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- DAS28-CRP
研究概览
简要总结
The aim of this study is to assess the efficacy of upadacitinib, methotrexate combination therapy in comparison to tofacitinib, methotrexate combination therapy in moderate to severe RA patients. This study will guide us to treat RA patients with inadequate response to methotrexate more effectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients of both gender (age ≥18 years). 2.Patients fulfill the ACR/EULAR 2010 classification criteria for rheumatoid arthritis.
- •3.Patients with DAS-28 CRP >3.2 despite optimum dose and duration of methotrexate (20-25 mg/week for minimum one month).
排除标准
- •1.Recent or concurrent infection
- •2.Active or latent tuberculosis
- •Hemoglobin (Hb) < 8 g/dl
- •White blood cell count < 4000/ micro L, Neutrophil count < 1000/ micro L, Platelet count < 100000/mm3
- •Live vaccines (rota virus, varicella, yellow fever) within 3 months prior to the first dose
- •Child-Pugh Class -C
- •Pregnant or planned for pregnancy and breastfeeding females of child-bearing potential
- •Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
- •New York Heart Association Class III and IV congestive heart failure
- •Previous history of thromboembolism, deep venous thrombosis, stroke, IHD
研究组 & 干预措施
Efficacy of upadacitinib, methotrexate combination therapy versus tofacitinib, methotrexate combinat
干预措施: To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis (Drug)
结局指标
主要结局
DAS28-CRP
时间窗: Outcome 1:"Disease Activity Score 28 CRP (DAS28-CRP) at week 4" Outcome 2:"Disease Activity Score 28 CRP (DAS28-CRP) at week 12" Outcome 3:"Disease Activity Score 28 CRP (DAS28-CRP) at week 24"
Number of Participants with Low disease activity or Remission as Assessed by DAS28-CRP, Change from Baseline in Pain Scores on the Visual Analog Scale at 24Weeks).
次要结局
未报告次要终点
研究者
Md Anisul Islam
Director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh