FAITHFUL Study

JRCT ID: jRCTs031230673

Registered date:05/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 05/03/2024
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Patients are randomly assigned by a centralized system in a 1:1 ratio to one of two open-label treatment groups: FIL added to MTX or bDMARDs-MTX (Add-on group) or FIL switched from MTX or bDMARDs-MTX (Switch group). The dose of FIL is 200 mg/day, and MTX was maintained at the same dose as the baseline unless a clinically relevant AE occurred.

Outcome(s)

• Primary Outcome: Change in DAS28-CRP from baseline at week 24

Secondary Outcome

1) Achievement rate of remission with DAS28-CRP, SDAI, CDAI or Boolean criteria at each visit
2) Achievement rate of low disease activity with DAS28-CRP, SDAI, CDAI or Boolean criteria at each visit
3) Change in DAS28-CRP, SDAI, CDAI at each visit
4) Achievement rates of ACR20/50/70 at each visit
5) Achievement rate of functional remission with HAQ (HAQ =< 0.5) at each visit
6) Achievement rate of structural remission with modified total Sharp (mTSS =< 0.5) score at weeks 24 and 48
7) Cumulative CRP and MMP-3 levels (area under the curve of CRP and MMP-3)
8) Work Productivity and Activity Impairment Questionnaire (WPAI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age >= 18 years
2) RA diagnosed with either the 1987 ACR criteria or 2010 ACR/ EULAR criteria
3) 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
4) Swollen joint count >= 2 and tender joint count >= 2
5) Not taking any JAKi before
6) Not taking csDMARDs other than MTX within 4 weeks of baseline
7) Prednisolone (or equivalent) =< 10 mg/day
8) Written informed consent provided

Exclude criteria

1) Pregnancy or hope to bear a child
2) Contraindication to FIL or MTX
3) eGFR =< 30
4) AST/ALT > Upper limit of normal x 5
5) WBC < 2000 uL
6) PLT < 100,000/uL
7) With a history of venous thromboembolism within 2 months before obtaining informed consent
8) With a history of acute interstitial pneumonia within 2 months before obtaining informed consent
9) With a history of herpes zoster within 2 months before obtaining informed consent
10) Ineligible for the study judged by physicians

Related Information

• Primary Sponsor: Kaneko Yuko
• Source(s) of Monetary Support: Gilead Sciences, Inc