CTRI/2023/06/054429招募中4 期
Comparison of parenteral to oral split-dose methotrexate in terms of efficacy and intracellular methotrexate polyglutamate levels – A randomized controlled trial - SCOOTS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- PGIMER
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
- •1.1. Meeting ACR/EULAR criteria 2010
- •2. RF or Anti-CCP positive
- •3. Given informed Consent
- •4. Weight at least 40 kg
- •5.TJC28 of atleast 6 AND SJC 28 of atleast 3
- •6. Not in Class 4 functional status (fully dependant)
- •7. Duration of RA of less than or equal to 3 years
排除标准
- •1. Currently on methotrexate /leflunomide/ sulfasalzine or has received them in the last 3 months
- •2. Taken JAKI in last 1 month
- •3,. Taken biological agents (TNF inhibitors or rituximab in last 6 months)
- •4. Pregnant/lactating OR planning pregnancy
- •5. 5. IM Steroid in last 7 days or Oral Pred >10 mg/d
- •6. Low blood counts (Hb <7, TLC <4000, Plt <100,000)
- •7. Raised transaminases (SGOT or SGPT >50 IU/L)
- •8. Creatinine >1.3mg/dL
- •9. K/C/O Chronic liver disease
- •10. K/C/O Chronic lung disease - bronchiectasis/ILD with FVC <70%
- •11. HepB/Hep C/HIV +ve OR Active TB or other infections
研究者
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