跳至主要内容
临床试验/CTRI/2026/01/100720
CTRI/2026/01/100720尚未招募不适用

A Comparative Study to Evaluate the Efficacy and Safety of Tofacitinib and Methotrexate as Monotherapy versus their Combination in the Management of Rheumatoid Arthritis

Eras Lucknow Medical College Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Effectiveness of treatment evaluated by End Study Investigation and ACR20/ACR50/ACR70 response evaluation.

研究概览

简要总结

This Observational trial is being done to evaluate the efficacy and safety of Tofacitinib and Methotrexate as mono-therapy versus their combination, in the management of Rheumatoid Arthritis for post graduation thesis submission for the department of Pharmacology.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age 18 or more than 18 years both males and females.
  • Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)[A score of greater than or equal to 6/10 confirms the diagnosis of Rheumatoid Arthritis].

排除标准

  • Any chronic systemic disease of liver, kidney, lungs and gastrointestinal tract.
  • Other joint diseases (e.g. Osteoarthritis, Gout, Ankylosing Spondylitis) Severely immuno-compromised patient.
  • Pregnant or breastfeeding women.
  • Patient having contraindication for methotrexate(e.g. chronic liver disease, Bone marrow suppression, Active infections, Severe renal impairment).

结局指标

主要结局

Effectiveness of treatment evaluated by End Study Investigation and ACR20/ACR50/ACR70 response evaluation.

时间窗: 4 Wk 8 Wk 12 Wk 16 Wk 20 Wk and 24 weeks.

次要结局

未报告次要终点

研究者

发起方
Eras Lucknow Medical College Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Singh Shashikumar Jitendra

Eras Lucknow Medical college and hospital

研究点 (1)

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