Table 1.

Patient populations.

Study	Tx	Analysis Set	Prior RA Tx	Rescue, weeks^a	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 allowed^b		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 DB^c
	ADA				52 DB^d
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
LTE^e
RA-BEYOND; NCT01885078	Baricitinib 4 mg	2 mg-4 mg-extended	Varied	PRN	Up to 5 years^f
RA-BEYOND; NCT01885078	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.