Study | Duration | Key inclusion criteria | Selected key exclusion criteria | Design | Doses | Concomitant medications |
---|---|---|---|---|---|---|
JADA21 NCT01185353 | 24 weeks | Adult-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 bDMARDs | Phase 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 days | Active RA | Phase 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 months | Active* RA with inadequate response to any DMARD | History 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-blinded | Moderately 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 weeks | Active RA*, prior MTX therapy for ≥12 weeks prior to study entry with inadequate response | Previous bDMARD therapy, selected lab abnormalities, recent clinically serious infection | Phase 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) NCT01721044 | 24 weeks | Moderately 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 abnormalities | Phase 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) NCT01721057 | 24 weeks | Moderately 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) NCT01711359 | 52 weeks | Active RA* No prior use of cDMARDs or bDMARDs No or limited exposure to MTX | Recent clinically significant infection, selected lab abnormalities | Phase 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, JADA | Baricitinib 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.