Filgotinib Add-on versus swITcH to Filgotinib in patients with rheUmatoid arthritis who inadequateLy responded to methotrexate(FAITHFUL Study)

未提供0 个研究点目标入组 120 人开始时间: 2024年5月23日最近更新: 2025年3月11日

适应症

试验速览

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•Age >= 18 years
•RA diagnosed with either the 1987 ACR criteria or 2010 ACR/ EULAR criteria
•Moderate or high disease activity based on DAS28-CRP >= 3.2 despite treatment with stable doses of >= 6 mg/week of MTX or bDMARDs-MTX for at least 8 weeks before enrolment
•Swollen joint count >= 2 and tender joint count >= 2
•Not taking any JAKi before
•Prednisolone (or equivalent) =< 10 mg/day
•Written informed consent provided

•Pregnancy or hope to bear a child
•eGFR =< 30
•AST/ALT > Upper limit of normal x 5
•WBC < 2000 uL
•PLT < 100,000/uL
•With a history of venous thromboembolism within 2 months before obtaining informed consent
•With a history of acute interstitial pneumonia within 2 months before obtaining informed consent
•With a history of herpes zoster within 2 months before obtaining informed consent
•With a history of hypersensitivity to either component FIL or MTX
•Breastfeeding patients
•With pleural or ascites effusions
•With active tuberculosis
•Ineligible for the study judged by physicians

Change in DAS28-CRP from baseline at week 24

Achievement rate of remission(each visit)
Achievement rate of low disease activity(each visit)
Change in DAS28-CRP, SDAI, CDAI(each visit)
Achievement rates of ACR20/50/70(each visit)
Achievement rate of functional remission with HAQ(each visit)
Percentage of Clinical relevant radiographic progression (CRRP) or Rapid radiographic progression (RRP)
Cumulative CRP and MMP-3 levels
Work Productivity and Activity Impairment Questionnaire (WPAI)
Achievement rate of structural remission with modified total Sharp score(weeks 24 and 48)

发起方

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