Efficacy and Safety Study of BIIB017

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: BIIB017 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biogen Idec

Overall contact:
Biogen Idec, MD, Email: ADVANCEstudy@biogenidec.com

To determine if treatment with BIIB017 can decrease the number of MS relapses during a certain time period for patients with RMS. Other goals of the study are to determine if, over time, BIIB017 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo.

Secondary outcome: To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability.

Detailed description: BIIB017, a PEGylated form of interferon beta-1a (IFN β-1a), is being developed as a novel therapeutic agent for the treatment of multiple sclerosis (MS). Despite recent approval of new therapeutic agents for MS, there continues to be a high unmet medical need in this patient population.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Aged 18 to 65 years old, inclusive, at the time of informed consent.

- Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4

- Must have an EDSS score between 0. 0 and 5. 0.

- Must have experienced at least 2 relapses that have been medically documented within

the last 3 years with one occurring in the last 12 months

Exclusion Criteria:

- Other chronic disease of immune system, malignancies, urologic, pulmonary,

gastrointestinal disease

- Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Biogen Idec, MD, Email: ADVANCEstudy@biogenidec.com

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Starting date: May 2009
Last updated: December 1, 2011