Study | Tx | Analysis Set | Prior RA Tx | Rescue, weeksa | Period Length, weeks |
---|---|---|---|---|---|
Phase Ib | |||||
14V-MC-JADB11, open label | Baricitinib 15 mg | All-bari-RA | Background MTX | — | 28 days |
Baricitinib 10 mg | |||||
Baricitinib 5 mg BID | |||||
Phase II | |||||
NCT0118535312 | Placebo | Placebo-4 mg | MTX-IR | — | 12 DB |
Baricitinib 8 mg | Placebo-2 mg-4 mg | bDMARD naive | 12 BE | ||
Baricitinib 4 mg | 2 mg-4 mg-extended | 52 OE | |||
Baricitinib 2 mg | All-bari-RA | 52 OE | |||
Baricitinib 1 mg | |||||
NCT00902486 | Placebo | Placebo-4 mg | csDMARD-IR | — | 12 DB |
Baricitinib 10 mg | All-bari-RA | Prior bDMARD allowed | 12 BE | ||
Baricitinib 7 mg | |||||
Baricitinib 4 mg | |||||
NCT0146901313, Japan, NCT01469013 | Placebo | Placebo-4 mg | MTX-IR | — | 12 DB |
Baricitinib 8 mg | Placebo-2 mg-4 mg | Prior bDMARD allowedb | 52 BE | ||
Baricitinib 4 mg | 2 mg-4 mg-extended | ||||
Baricitinib 2 mg | All-bari-RA | ||||
Baricitinib 1 mg | |||||
Phase III | |||||
RA-BEAM7; NCT01710358 | Placebo | Placebo-4 mg | MTX-IR | 16 | 24 DB |
Baricitinib 4 mg | All-bari-RA | bDMARD naive | 28 DBc | ||
ADA | 52 DBd | ||||
RA-BEACON8; NCT01721044 | Placebo | Placebo-4 mg | TNFi-IR | 16 | 24 DB |
Baricitinib 4 mg | Placebo-2 mg-4 mg | ||||
Baricitinib 2 mg | 2 mg-4 mg-extended, all-bari-RA | ||||
RA-BUILD9; NCT01721057 | Placebo | Placebo-4 mg | csDMARD-IR | 16 | 24 DB |
Baricitinib 4 mg | Placebo-2 mg-4 mg | bDMARD naive | |||
Baricitinib 2 mg | 2 mg-4 mg-extended, all-bari-RA | ||||
RA-BEGIN10; NCT01711359 | MTX mono | All-bari-RA | DMARD naive | 24 | 52 DB |
Baricitinib 4 mg mono | |||||
Baricitinib 4 mg + MTX | |||||
LTEe | |||||
RA-BEYOND; NCT01885078 | Baricitinib 4 mg | 2 mg-4 mg-extended | Varied | PRN | Up to 5 yearsf |
Baricitinib 2 mg | All-bari-RA |
↵a First available rescue.
↵b Prior bDMARD allowable; however, patients could not have stopped treatment as a result of insufficient response.
↵c Double-blind with no placebo.
↵d Trial RA-BEAM had 24 weeks of placebo control and 52 weeks of active control.
↵e Studies contributing to LTE RA-BEYOND included phase II trial NCT01185353 and phase III trials RA-BEAM, RA-BEACON, RA-BUILD, and RA-BEGIN.
↵f Ongoing trial with data as of September 1, 2016. RA: rheumatoid arthritis; IR: incidence rate; BID: twice daily; DB: double-blind; bDMARD: biological disease-modifying antirheumatic drug; BE: blinded extension with no placebo; csDMARD: conventional synthetic DMARD; ADA: adalimumab; LTE: longterm extension; MTX: methotrexate; OE: open-label extension; PRN: pro re nata (as needed); TNFi: tumor necrosis factor inhibitor.