Table 1

Key features of filgotinib RA phases 2 and 3 studies

Required background medicationControlProtocol-defined rerandomisation to FIL
NoneMTXcsDMARD(s)PBOActive comparator
Phase 3 studies
FINCH 1
NCT02889796
X24 weeks52 weeks (ADA)PBO patients at week 24
FINCH 2
NCT02873936
X24 weeks
FINCH 3*
NCT02886728
XNA52 weeks (MTX)
FINCH 4 (LTE)
NCT03025308
X†NAAt study entry‡
Phase 2 Studies
DARWIN 1
NCT01668641
X24 weeksNon-responders at week 12
DARWIN 2
NCT01894516
X12 weeksPBO patients and nonresponders at week 12
DARWIN 3 (LTE)
NCT02065700
NAAt study entry¶
  • *In addition to filgotinib 200 mg +MTX and filgotinib 100 mg +MTX, this trial included a filgotinib 200 mg monotherapy treatment arm.

  • †Patients continued to receive parent study protocol-approved background medication; patients in FINCH 3 receiving MTX discontinued on enrolment in FINCH 4.

  • ‡All patients who received FIL at the time of completion of parent study continued to receive blinded FIL dose (100 mg once a day or 200 mg once a day). Patients who received ADA, PBO or MTX monotherapy, or who completed FINCH 2 on standard of care, were rerandomised at LTE entry to receive either FIL 100 mg or FIL 200 mg. Patients from FINCH 1 and FINCH 3 who completed parent study on standard of care were not eligible.

  • §Patients were permitted to restart background MTX therapy if deemed necessary by the investigator.

  • ¶Patients who received FIL 200 mg once a day or FIL 100 mg two times per day at the time of completion of parent study continued to receive the same FIL dose in the LTE study. Patients who received FIL 25 mg two times per day, FIL 50 mg once a day, FIL 50 mg two times per day or FIL 100 mg at the time of completion of parent study were assigned either FIL 200 mg once a day or FIL 100 mg two times per day at LTE entry. Patients who received PBO at the time of completion of parent study were rerandomised at LTE entry to receive either FIL 200 mg once a day or FIL 100 mg two times per day. In the USA, dosing in male subjects was restricted to FIL 100 mg once a day.

  • ADA, adalimumab; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FIL, filgotinib; LTE, long-term extension; MTX, methotrexate; NA, not applicable; PBO, placebo; RA, rheumatoid arthritis.