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Efficacy and SafetyClinical Efficacy RAORAL StrategyReal-World EvidenceORAL Surveillance and Integrated Safety SummaryClinical Efficacy PsAOPAL Clinical ProgrammeClinical Efficacy UCOCTAVE Study DesignOCTAVE Clinical ProgrammeSub GroupsPost-hoc AnalysesSafety and TolerabilitySafety Profile SummarySpecial Warnings & Precautions for UseAboutXELJANZ Mechanism of ActionDosing and AdministrationDosing in RA & PsADosingDosing in UCDosingSupport & ResourcesSupport & ResourcesMaterials
OCTAVE Study DesignThe XELANZ clinical development programme for ulcerative colitis includes one phase II and three phase III clinical trials and one long-term extension (LTE) study, OCTAVE Open.

The efficacy and safety of XELJANZ for the treatment of adult patients with moderately to severely active ulcerative colitis was demonstrated in three Phase III randomised, double-blind, placebo ­controlled trials (RCTs): OCTAVE Induction 1 and 2, and OCTAVE Sustain1

  • OCTAVE Induction 1 and 2 were two identical studies of patients with moderately to severely active disease to assess the efficacy and safety of XELJANZ in inducing remission.1
  • OCTAVE Sustain was a study of patients who had achieved clinical response in the two OCTAVE Induction studies to assess the efficacy and safety of XELJANZ in maintaining remission.1
  • Patients in the OCTAVE Phase III trial programme were eligible to enter an open-label extension study, OCTAVE Open.1
Study Designs1,2

*Final complete efficacy assessment at Week 8/52
BID= twice daily, LTE= long-term extension

In the OCTAVE Phase III studies, outcomes were measured for disease activity, health-related quality of life and health utility using multiple endpoints1,3:

  • The primary and key secondary endpoints were clinical outcomes based on the Mayo score.
  • The Mayo endoscopic subscore, based on mucosal appearance during endoscopy, was assessed by central and local readings. Central assessment was by a central reader using video recorded during the procedure; local assessment was done by the study site investigator.
  • The central reading was used for eligibility and primary efficacy endpoint analysis. The OCTAVE programme was the first in ulcerative colitis to use central reads to assess primary efficacy endpoints.
  • Local readings are more likely to reflect clinical practice where physicians use their own assessment of endoscopic findings to complement other data to make clinical decisions.
The primary and key secondary endpoints for OCTAVE Induction 1 and 2 and OCTAVE Sustain are shown in the table below.

Clinical response is also defined as it was the criteria for entry into OCTAVE Open.
Learn more about the OCTAVE clinical programme Learn more Loading

Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information

In the OCTAVE UC trials, remission was defined more stringently than in previous clinical trials for UC, by including the requirement of a rectal bleeding subscore of 0.3

References:Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.XELJANZ Summary of Product Characteristics.Pouillon L. Bossuyt P. Peyrin-Biroulet L. Gastroenterology 2017; 153(3): 862-864.
Clinical Efficacy in UC

Learn more about the XELJANZ safety profile

See safety profile summary

Learn about dosing in UC

See recommended dosing

Find out more about how XELJANZ works

See how XELJANZ works

Legal Category: S1A
Further information is available upon request

PP-XEL-IRL-0782 January 2023

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Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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