Multiple Sclerosis Study Using Ocrelizumab

• Research type

  Research Study

• Full title

  An Open Label Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients with Relasping Remitting Multiple Sclerosis who have had a Suboptimal Response to an Adequate Course of Disease- Modifying Treatment

• IRAS ID

  200579

• Contact name

  Benjamin Turner

• Contact email

  Benjamin.Turner@bartshealth.nhs.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2015-005597-38

• Duration of Study in the UK

  4 years, 10 months, 5 days

• Research summary

  This phase IIIb study is designed to assess the efficacy & safety of a new study drug: Ocrelizumab, in patients diagnosed with relapsing remitting multiple sclerosis (RRMS) who have had a suboptimal response to an adequate course of a disease modifying treatment (DMT) administered for at least 6 months.
  Eligible patients will be assessed for efficacy and safety every 24 weeks. The study will consist of the following:

  • Screening – Up to 4 weeks
  • Treatment – over 96 weeks (last dose administered at week 72)
  • Follow-up – over 96 weeks

  The first dose of Ocrelizumab will be administered as an initial dose of two 300mg infusions (600 mg total) separated by 14 days, followed by one 600 mg infusion every 24 weeks for the study duration. A maximum of 4 complete doses will be given. Patients that complete the study treatment will have the option to continue on commercial Ocrelizumab if available and/or transition into a separate Ocrelizumab Long Term Extension Study.

  Following the completion or early discontinuation of treatment, patients that choose to remain on this study will be followed up for at least 96 weeks after the last infusion of the study drug. Patients whose B-cells have not fully recovered after 96 weeks of follow-up will continue with visits every 24 weeks and telephone contacts every 8 weeks until B-cell repletion.

  A structured telephone interview will be conducted by hospital staff every 8 weeks between the hospital visits during the treatment period and follow-up period to identify and collect information on any changes in the patient’s health status that warrants an unscheduled hospital visit. Safety will be assessed throughout the study.

  This study will enroll 600 patients globally, there are 24 sites planned in the UK.

  The total length of the study is expected to be approximately 5 years.

  This study is sponsored by Roche Products Ltd in the UK.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  16/LO/0586

• Date of REC Opinion

  19 May 2016

• REC opinion

  Further Information Favourable Opinion