Efficacy and Safety of Baricitinib in Different Doses for the Treatment of Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Disease activity score 28-C-reactive protein (DAS28-CRP)
研究概览
简要总结
This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.
详细描述
This open label randomized controlled clinical trial will be conducted in the department of Rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to severe disease activity (DAS 28 ESR/CRP>3.2) despite treatment with methotrexate or other csDMARDs will be considered as primary entry criteria for this study. Simple random sampling method will be applied. After a washout period of three weeks, Group A will be put on baricitinib 2 mg once daily and Group B will be put on baricitinib 4 mg once daily. Methotrexate 10mg will be used on both groups in addition to barcitinib. NSAIDs and adjuvant analgesics will be used if needed. All the patients will go through baseline evaluation before treatment which include-Disease Activity Score derivative for 28 joints (DAS 28ESR/CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and laboratory tests like CBC, CRP, SGPT, Serum Creatinine, LDH, RF, ACPA, Chest X-ray P/A view and TST or interferon gamma release assay (IGRA). Follow up will be done at 4th, 12th and 24th week. Response to treatment will be evaluated by DAS 28 ESR/CRP. Primary endpoint for efficacy will be assessed at the end of 24th week by DAS 28 CRP response. Secondary endpoints will be determined by SDAI, CDAI and HAQ-DI. Adverse effects will be assessed by history, physical examinations and investigations
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
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
- •age greater than 18 years
- •patients fulfill the ACR/EULAR 2010 classification criteria for RA
- •DAS-28 CRP more than 3.2 despite optimum dose of methotrexate
排除标准
- •Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization
- •Hemoglobin (Hb) < 8 g/dl
- •White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3
- •Live vaccines within 3 months prior to the first dose
- •Serum creatinine > upper limit of normal reference range
- •eGFR < 60 ml/minute/1.73 m2
- •Alanine transaminase (ALT) more than ULN
- •Pregnant or breast feeding 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, diverticulitis
研究组 & 干预措施
Baricitinib 2mg and methotrexate 10mg
Baricitinib 2mg once daily plus methotrexate 10mg per week
干预措施: Baricitinib 2 MG (Drug)
Baricitinib 4mg and methotrexate 10mg
Baricitinib 4mg once daily plus methotrexate 10mg per week
干预措施: Baricitinib 4 MG Oral Tablet (Drug)
结局指标
主要结局
Disease activity score 28-C-reactive protein (DAS28-CRP)
时间窗: 6 months
Disease activity score in 28 joints has to measure at 6 months. score less than or equal 3.2 will be regarded as low disease activity
次要结局
- Disease activity score 28-C-reactive protein (DAS28-CRP)(6 months)
- Clinical Disease activity index (CDAI)(6 months)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(6 months)
研究者
Dr. Md. Sadikul islam
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh