Rheumatoid arthritis
Conditions
Interventions
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
Sponsors
Kaneko Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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) Prednisolone (or equivalent) =< 10 mg/day 7) Written informed consent provided
Exclusion criteria
Exclusion criteria: 1) Pregnancy or hope to bear a child 2) eGFR = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DAS28-CRP from baseline at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 == 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) | — |
Contacts
Public ContactMitsuhiro Akiyama
Keio University Hospital
Outcome results
None listed