A study to evaluate switching therapy to Natalizumab in MS patients

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis. Protocol number: 101MS325

• IRAS ID

  37412

• Contact name

  Eli Silber

• Sponsor organisation

  Biogen Idec Limited

• Eudract number

  2009-015556-15

• Research summary

  A PHASE 3B STUDY IN PARTICIPANTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS (MS) TO EVALUATE THE BENEFITS OF SWITCHING THERAPY TO NATALIZUMAB.Current Disease Modifying Treatments (DMTs) are only partially effective and when patients continue to experience disease activity [new relapses or lesions on MRI (magnetic resonance imaging) scan], it is difficult for the patient and the doctor to decide what to do next. This study is being conducted to evaluate the benefits of switching treatment with Glatiramer Acetate (Copaxone©) or Interferon Ç?ð1a subcutaneous (SC), Rebif© (comparator drugs) to Natalizumab (Tysabri©) (study drug). All three drugs are currently approved treatments for MS.This is a multicentre, randomised, raterðblind, parallelðgroup activeðcontrolled study. Approximately 1800, aged 18ð60 years old, will be enrolled at 300 sites worldwide including the UK. Participants must have been treated with one of the comparator drugs as their principal first therapy for MS for 6ð18 months prior to randomisation.In the UK the study will be conducted by the Neurology Departments/centres with MS services at NHS Hospitals.Patients on treatment between 6-18 months who have had a new relapse or new MRI lesions will be offered to participate in this study. Patients that enrol on the study will be randomly assigned to one of the three treatment arms. They will have a 50% chance to be assigned to the study drug, Natalizumab and 25% to be assigned to either of the two comparator drugs Glatiramer Acetate or Interferon Ç?ð1a SC.Participants will be on the study for between 48 weeks and 96 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. These tests will be performed in order to assess the safety of the patient as well as the efficacy of the drug they have been assigned to. A 12ðweek postðtreatment telephone contact will be conducted for participants who do not continue natalizumab treatment at the end of the study.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  10/H0808/57

• Date of REC Opinion

  2 Sep 2010

• REC opinion

  Further Information Favourable Opinion