CTRI/2023/07/055919尚未招募3 期
A Randomized Open Label Study Comparing Effectiveness Of Combination Of Leflunomide, Sulfasalazine Or Tofacitinib With Methotrexate In Rheumatoid Arthritis With Methotrexate Inadequate Response - NI
Indian Rheumatology Association0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- •satisfying presence of classification criteria ACR/EULAR rheumatoid arthritis classification criteria 2010, has suboptimal response to maximal tolerated dose or 25mg stable dose for at least 6 weeks to methotrexate monotherapy defined by Disease Activity Score DAS 28 CRP >3.2 at 3 months.
排除标准
- •1 Blood dyscrasias at screening
- •2 Absolute white blood cell count (WBC) <3.0 x 109/L ( <3000 mm3)
- •3 Absolute neutrophil count (ANC) <1.5 x 109/L ( <1500 mm3)
- •4 Absolute lymphocyte count <1.0 x 109/L ( <1000/mm3)
- •5 Platelet count <100 x 109/L ( <100,000/mm3)
- •6 Estimated Creatinine Clearance <30 mL/min based on CKD-EPI at Screening.
- •7 Total bilirubin, AST or ALT more than 2 times the upper limit of normal (ULN) at screening
- •8 Patients having active tuberculosis or positive for latent tuberculosis as tested by QuantiFERON-TB Gold In Tube (QFT Gold test) or Montoux skin Test.
- •History of recurrent herpes zoster or herpes simplex.
- •History of lymphoproliferative disorder.
- •Present malignancy or with a history of malignancy
- •Pregnant female or breast feeding mothers.
- •History of Sulfa drug allergy.
研究者
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