CLINICAL TRIAL FOR SUBJECTS WITH RELAPSING MS (BIIB017)

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis.

• IRAS ID

  20732

• Contact name

  Cris S Constantinescu

• Eudract number

  2008-006333-27

• Clinicaltrials.gov Identifier

  00906399

• Research summary

  Multiple Sclerosis (MS) is a chronic disease of the central nervous system (CNS). Although there is still no cure for MS, effective therapies are available to modify the disease course and treat exacerbations, such as interferon beta and Copaxone (glatiramer acetate).Biogen Idec (the sponsor) is developing BIIB017 for MS. BIIB017 was well tolerated at doses ranging from 63 mcg to 188 mcg in Phase 1 studies. BIIB017 with a longer half-life and greater exposure to IFN ǟ÷-1a compared to Avonex (a drug with over 10 years of established efficacy and safety) is being developed to reduce side-effects (e.g.flulike symptoms), while increasing convenience and improving treatment compliance. The study is examining the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in patients with RMS after 1 year. This pivotal Phase 3 study will determine the efficacy and safety of 1 dose of BIIB017 (125mcg SC) and two dosing frequencies (every 2 weeks and 4 weeks) of B11B017 to treat Relapsing Multiple Sclerosis (RMS) patients over the course of 2 years. All subjects will receive a (SC) injection (self administration) of study treatment (either BIIB017 or placebo) every 2 weeks.Potential patients are screened for the following criteria; Aged 18 to 55 years old, Confirmed diagnosis of relapsing MS, *Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0. and at least 2 relapses within the last 3 years with at least one of these relapses having occurred within the past 12 months prior to randomization. Patients will keep a diary of their MS symptoms, do questionnaires, visit hospital to give blood/urine samples as well as less frequent tests as ECG to assess their well being over the course of the study. The UK is aiming to recruit circa 45 patients over approximately 5/6 hospitals in the country.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/88

• Date of REC Opinion

  3 Dec 2009

• REC opinion

  Further Information Favourable Opinion