GA29145 – Open label extension & safety monitoring study

• Research type

  Research Study

• Full title

  AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

• IRAS ID

  179243

• Contact name

  Ramesh Arasaradnam

• Contact email

  ramesh.arasaradnam@uhcw.nhs.uk

• Sponsor organisation

  F.Hoffmann-La Roche Ltd

• Eudract number

  2014-003855-76

• Clinicaltrials.gov Identifier

  NCT02394028

• Duration of Study in the UK

  7 years, 0 months, 0 days

• Research summary

  This is an open label extension study and safety monitoring study open to eligible patients who were enrolled in study GA29145. Patients can enter one or both parts of this study.

  The study is divided in two parts. Part 1 (open-label extension; OLE) will assess the long term safety and efficacy of etrolizumab via subcutaneous injections (SC). Patients will receive etrolizumab every 4 weeks until the patient enters
  Safety monitoring (SM) (Part 2). As a substantial proportion of patients enrolling in this study may be receiving etrolizumab for the first time, all patients will be required to receive their first five doses (Week 0, 4, 8 and Week 12) of
  etrolizumab in the clinic setting and be monitored for 60 minutes following each dose. After this and if they are happy to do so, patients can continue to self administer the medication themselves at home.
  Part 1 (OLE) will continue for up to 3 years after the first patient is enrolled into the study unless the Sponsor decides it is necessary to terminate the study earlier. Patients who withdraw from Part 1 (OLE) should complete the 12 week safety follow up and then enter Part 2 (SM) for PML monitoring.
  Part 2 (safety monitoring SM), will assess the long term safety of etrolizumab. Patients will not receive etrolizumab and will be followed up until 2 years after their last dose of etrolizumab. Part 2 will consist of telephone calls from the study
  doctor or study personnel approximately every 6 months to assess patients for any signs or symptoms of PML (progressive multifocal leukoencephalopathy).

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  15/NE/0144

• Date of REC Opinion

  13 Jul 2015

• REC opinion

  Further Information Favourable Opinion