SEAVUE - Safety and Efficacy of Adalimumab Vs Ustekinumab for one yEar

• Research type

  Research Study

• Full title

  A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease

• IRAS ID

  248843

• Contact name

  Peter Irving

• Contact email

  peter.irving@gstt.nhs.uk

• Sponsor organisation

  Janssen Cilag-International NV

• Eudract number

  2017-004209-41

• Clinicaltrials.gov Identifier

  NCT03464136

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  2 years, 2 months, 9 days

• Research summary

  The purpose of this study is to compare the effects (both good and bad) of ustekinumab to those of adalimumab. Both ustekinumab and adalimumab are drugs already used to treat moderately to severely active Crohn’s disease.
  About 350 patients will take part in this worldwide study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/1192

• Date of REC Opinion

  21 Aug 2018

• REC opinion

  Further Information Favourable Opinion