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临床试验/CTRI/2024/04/065955
CTRI/2024/04/065955尚未招募3 期

A Comparative study to evaluate the efficacy of Tofacitinib and Adalimumab in treating axial spondyloarthritis: An open label randomized controlled trial

Institute of post graduate graduate medical education and research1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月6日最近更新:
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试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
ASAS20 response
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, open label, parallel group, single center trial comparing the efficacy of Tofacitinib 5mg twice daily and Adalimumab 40mg subcutaneous 2 weekly for a duration of 16 weeks. Primary outcome will measure ASAS20 response at 16 weeks. Secondary outcomes will be ASAS20, ASAS40, ASAS 5/6, change in CRP, ASDASCRP, BASDAI, MASES, PGA at 4 weekly interval and change in BASFI,BASMI, ASQoL at 16weeks along with NSAID use.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • •Patients fulfilling the ASAS classification criteria for axial SpA including both non radiographic axial spondyloarthritis (nr-AxSpA) and ankylosing spondylitis (AS) Patients with BASDAI ≥4 or ASDAS-CRP≥2.
  • •Biologic DMARD (b DMARD) and targeted synthetic DMARD (ts DMARD) naïve patients who have undergone a trial of at least 2 courses of NSAIDs with optimum doses for at least 1 month without response or with partial response.
  • •Patients with prior b DMARD and ts DMARD permitted if discontinued for ≥4 weeks or ≥5 half-lives (whichever was longer) before randomization.

排除标准

  • 未提供

结局指标

主要结局

ASAS20 response

时间窗: ASAS20 response

次要结局

  • ASAS20 response(4, 8, 12 and 16 weeks)
  • ASAS40 response(4,8, 12 and 16 weeks)
  • Change in ASADASCRP(4,8,12 and 16 weeks)
  • Change in hsCRP(4,8,12 and 16 weeks)
  • Change in BASDAI(4,8,12 and 16 weeks)
  • ASAS 5/6 response(4,8,12 and 16 weeks)
  • Change in BASMI(16 weeks)
  • Change in BASFI(16 weeks)
  • Change in ASQoL(16 weeks)
  • Change in patient global assessment(4,8,12 and 16 weeks)
  • Incident and severity of adverse effects(4,8,12 and 16 weeks)
  • Change in MASES(4,8,12 and 16 weeks)
  • Change in swollen joint count(4,8,12 and 16 weeks)
  • NSAID use(4,8,12 and 16 weeks)
  • BASDAI50 response(4,8,12 and 16 weeks)

研究者

发起方
Institute of post graduate graduate medical education and research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Monika G

IPGMER and SSKM hospital

研究点 (1)

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