臨床研究等提出・公開システム

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

FAITHFUL Study

Kaneko Yuko

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

ykaneko.z6@keio.jp

Akiyama Mitsuhiro

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5363-3786

mitsuaki@keio.jp

Not Recruiting

Mar. 05, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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) Prednisolone (or equivalent) =< 10 mg/day
7) Written informed consent provided

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

Both

Rheumatoid arthritis

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.

Arthritis, Rheumatoid

Change in DAS28-CRP from baseline at week 24

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 from baseline 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 (change from baseline in mTSS =< 0.5) score at weeks 24 and 48
7) Percentage of Clinical relevant radiographic progression (CRRP, change from baseline in mTSS >= 3) or Rapid radiographic progression (RRP, change from baseline in mTSS >= 5)
8) Cumulative CRP and MMP-3 levels (area under the curve of CRP and MMP-3)
9) Work Productivity and Activity Impairment Questionnaire (WPAI)

+81-3-5363-3503

Sept. 27, 2023

No

none