Table 1

Summary of studies

StudyDurationKey inclusion criteriaSelected key exclusion criteriaDesignDosesConcomitant medications
JADA21
NCT01185353
24 weeksAdult-onset RA for ≥6 months (<15 years)
Regular use of MTX ≥12 weeks prior to study entry, stable dose ≥8 weeks prior
Previous use of bDMARDsPhase 2b, RCT, dose-ranging, 69 centres in 9 countries
301 Patients randomised
Randomisation to once-daily placebo (n=98), baricitinib 1 mg (n=49), 2 mg (n=52), 4 mg (n=52), or 8 mg (n=50)
Placebo or baricitinib 1 mg re-randomised to baricitinib 2 mg two times per day or baricitinib 4 mg once daily
Stable csDMARDs (MTX, HCQ, SSZ), NSAIDs, corticosteroids
JADB
Not registered
28 daysActive RAPhase 1b, open-label, dose ranging
53 Patients randomised
Baricitinib 5 mg two times per day (n=17) or baricitinib 10 mg (n=18) or 15 mg once daily (n=18)MTX
JADC22
NCT00902486
6 monthsActive* RA with inadequate response to any DMARDHistory of infection requiring systemic therapy
History of neutropenia, thrombocytopenia or anaemia requiring transfusion
Phase 2, RCT, parallel-group, dose-ranging, 49 locations in 2 countries
127 Patients randomised
Randomisation to once-daily placebo (n=31) or baricitinib 4 mg (n=32), 7 mg (n=32), or 10 mg (n=32)
Placebo cross over to baricitinib 7 mg, or 10 mg once daily
Stable csDMARDs (MTX, HCQ, SSZ), NSAIDs, corticosteroids
JADN23
NCT01469013
12-week double-blinded then 52-week single-blindedModerately to severely active RA* for ≥6 months (<15 years)
Regular use of MTX ≥12 weeks prior to study entry, stable dose ≥8 weeks prior
csDMARD and/or sulfasalazine use ≤8 weeks prior to study enrolment
Insufficient response to previous bDMARD therapy
Phase 2b, 24 centres in Japan
145 Patients randomised
Randomisation to once-daily placebo (n=49) or baricitinib 1 mg (n=24), 2 mg (n=24), 4 mg (n=24) or 8 mg (n=24)
Placebo or baricitinib 1 mg or 2 mg re-randomised to baricitinib 4 mg or 8 mg once daily
Stable MTX and/or SSZ, corticosteroids
JADV (RA-BEAM18)
NCT01710358
52 weeksActive RA*, prior MTX therapy for ≥12 weeks prior to study entry with inadequate responsePrevious bDMARD therapy, selected lab abnormalities, recent clinically serious infectionPhase 3, RCT, active control, parallel-group, 281 centres in 26 countries
1307 Patients randomised
Patients randomised to placebo (n=488) or baricitinib 4 mg once daily (n=487) or adalimumab 40 mg every other week (n=330)
Placebo switch to baricitinib 4 mg at 24 weeks
Rescue to baricitinib 4 mg at week 16 for patients with <20% improvement from baseline at weeks 14 and 16
Existing medications (including MTX) taken at study entry were continued throughout the study
JADW (RA-BEACON17) NCT0172104424 weeksModerately to severely active RA*
Required use of ≥1 csDMARD regularly for 12 weeks prior to study entry (steady dose for ≥8 weeks)
Insufficient response to TNF inhibitors after 3 months of use
Recent clinically significant infection, selected lab abnormalitiesPhase 3, RCT, 178 centres in 24 countries
527 Patients randomised
Randomisation to placebo (n=176), or once-daily baricitinib 2 mg (n=174) or baricitinib 4 mg (n=177)
Rescue medication (baricitinib 4 mg) assigned at week 16 for patients with <20% improvement from baseline
Concomitant stable doses of csDMARDs, NSAIDs, analgesics, corticosteroids permitted
JADX (RA-BUILD19) NCT0172105724 weeksModerately to severely active RA*
Insufficient response/intolerance to ≥1 cDMARD
Prior bDMARD use, selected lab abnormalities, current or recent clinically significant comorbidity (including infection)Phase 3, RCT, parallel-group, 182 study centres in 22 countries
684 Patients randomised
Randomisation to once-daily placebo (n=228), baricitinib 2 mg (n=229), or baricitinib 4 mg (n=227)
Rescue to baricitinib 4 mg at week 16 for patients with <20% improvement from baseline at both week 14 and 16
Up to two concomitant csDMARDs permitted (not required) at study entry†;
Concomitant corticosteroids permitted with stable doses 6 weeks prior to randomisation
JADZ (RA-BEGIN20) NCT0171135952 weeksActive RA*
No prior use of cDMARDs or bDMARDs
No or limited exposure to MTX
Recent clinically significant infection, selected lab abnormalitiesPhase 3, RCT, double-dummy, active comparator, 198 centres in 18 countries
584 Patients randomised
Randomisation to oral MTX monotherapy once-weekly (n=210), baricitinib 4 mg once-daily monotherapy (n=159); or baricitinib + MTX (n=215)
Rescue to baricitinib + MTX at week 24 for patients with <20% improvement from baseline
Stable doses of NSAIDs, analgesics or oral corticosteroids permitted
JADY
NCT01885078
Long-term extension (LTE)Patients from studies JADV, JADZ, JADX, JADW, JADABaricitinib 2 mg or 4 mg once daily
  • *Active RA defined as ≥6/68 tender joints and ≥6/66 swollen joints, CRP ≥3.6 mg/L.

  • †Concomitant cDMARD required to have been used ≥12 weeks prior to study entry with stable doses for ≥8 weeks prior.

  • ACPA, anti-citrullinated protein antibodies; bDMARD, biological disease-modifying drug; csDMARD, conventional synthetic disease-modifying drug; hsCRP, high-sensitivity C reactive protein; HCQ, hydroxychloroquine; MTX, methotrexate; NSAIDs, nonsteroidal anti-inflammatory drugs; RA, rheumatoid arthritis; RCT, randomised controlled trial; RF, rheumatoid factor; SSZ, sulfasalazine; TNF, tumour necrosis factor.