Phase 3 study of the efficacy and safety of DAC HYP in MS patients

• Research type

  Research Study

• Full title

  Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis Protocol Number: 205MS301

• IRAS ID

  40232

• Contact name

  Benjamin Turner

• Sponsor organisation

  Biogen Idec Ltd

• Eudract number

  2009-012500-11

• Clinicaltrials.gov Identifier

  NCT01064401

• Research summary

  Patients with multiple sclerosis (MS) frequently have inadequate treatment options: approved first-line therapies often fail to stop disease progression while more effective alternatives may be delayed or withheld due to safety considerations. This trial is designed to test the hypothesis that DAC HYP monotherapy is superior to Interferon ǟ÷-1a (Avonex©) monotherapy for reducing MS disease activity. IFN ǟ÷-1a monotherapy (Avonex©) is currently an approved treatment for MS. This is a multicentre, randomised double-blind, parallel group, monotherapy, active-control study. Approximately 1500 participants, aged between 18-55 years old will be enrolled at approximately 265 sites worldwide across 28 countries. In the UK the study will be conducted by the Neurology Departments/centres with MS services at NHS Hospitals. Participants that enrol on the study will be randomly assigned to one of the two treatment arms (either Daclizumab HYP or Avonex©). They have a 50% chance of receiving either drug. Participants will be on the study for at least 96 weeks but no more than 144 weeks. During their participation, they will have a series of tests and assessments including blood and urine tests, completion of quality of life questionnaires, physical and neurological examinations and brain MRI (magnetic resonance imaging). These tests will be performed in order to assess the safety of the participant's well as the efficacy of the drug they have been assigned to. All participants who complete the study may be eligible for an open label extension study with the study drug, Daclizumab HYP. Participants who do not enter the extension study will have follow-up visits at 16 weeks and 24 weeks after the last dose of the study drug.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/11

• Date of REC Opinion

  4 May 2010

• REC opinion

  Further Information Favourable Opinion