Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial
- Westhovens, R.
- Rigby, W.F.C.
- Heijde, D. van der
- Ching, D.W.T.
- Stohl, W.
- Kay, J.
- Chopra, A.
- Bartok, B.
- Matzkies, F.
- Yin, Z.Y.
- Guo, Y.
- Tasset, C.
- Sundy, J.S.
- Jahreis, A.
- Mozaffarian, N.
- Messina, O.D.
- Landewe, R.B.M.
- Atsumi, T.
- Burmester, G.R.
DOIAbstract
Objectives To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.MethodsThis 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.ResultsThe primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (pPathophysiology and tr...
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