Efficacy
ORAL Strategy Study Design
12-month Phase IIIb/IV non-inferiority study in 1,146 patients with moderate to severe active RA with an inadequate response to MTX1
JAK, Janus kinase; MOA, mode of action
Patient population1
  •  
  • Moderate to severe RA.
  • MTX-IR.
  • N=1,146 randomised patients.
  • Global study.
  • Randomised, controlled clinical trial.
Primary efficacy endpoint1
  • The primary efficacy endpoint of the study was ACR50 at Month 6 (non-inferiority was assessed between treatment groups)*1
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Dosing in RA
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*XELJANZ + MTX was compared with adalimumab + MTX; and XELJANZ monotherapy was compared with both adalimumab + MTX and with XELJANZ + MTX.

ACR, American College of Rheumatology; BID, twice daily; IR, inadequate response; MTX, methotrexate; Q2W, once every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneous.
References
1. Fleischmann R et al. Lancet 2017; 390:457–468.
PP-XEL-GBR-3117. August 2021
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

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