CAIN457C22301E1

• Research type

  Research Study

• Full title

  A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)

• IRAS ID

  1010802

• Contact name

  Sebastiano Corridore

• Contact email

  sebastiano.corridore@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Clinicaltrials.gov Identifier

  NCT06331312

• Research summary

  The purpose of the present extension study (CAIN457C22301E1) is to assess the long-term safety and tolerability of secukinumab in PMR patients who have completed the 52-week treatment period (TP) of the core study, AND have experienced a recurrence of PMR symptoms (called relapse) during the 6 months treatment-free follow-up period of the core study AND meet all of the eligibility criteria (see Trial Population section below for more information on eligibility criteria).
  The study will also offer these patients an opportunity to have long-term/continued access to a potential PMR therapy, secukinumab.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  25/EM/0015

• Date of REC Opinion

  25 Feb 2025

• REC opinion

  Further Information Favourable Opinion