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
​​​​​​​Explore more
Dosing in RA
*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.
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.

© 2021 Pfizer Pte Ltd. All rights reserved.

The information provided in this site is intended only for Healthcare Professionals in Singapore. The products discussed herein may have different product labelling in different countries. Pfizer Pte Ltd, Singapore is a subsidiary of Pfizer Inc, a pharmaceutical company committed to helping people improve their health by discovering and developing medicines.