Source: National Multiple Sclerosis Society trial announcement (www.nationalmssociety.org), Aug 31, 2009
Summary: Investigators worldwide are recruiting 1,260 people with relapsing MS for a Phase III clinical trial comparing the effectiveness of BIIB017 (PEGylated interferon beta-1a, delivered under the skin) and inactive placebo. The study is sponsored by Biogen Idec.
Rationale: Avonex® (interferon beta-1a, Biogen Idec) is approved by the U.S. Food and Drug Administration for the treatment of people with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. BIIB017 is a “pegylated” form of the interferon beta-1a molecule. PEGylated molecules are attached to a molecule of polyethylene glycol, which enables them to maintain effects in the body for longer periods of time.
This formulation has been tested in healthy individuals in two phase I clinical trials, but has not yet been tested in people with MS. If proven to be safe and effective in treating MS, this drug may help to reduce the frequency of administration of interferon beta and the flu-like side effects that can occur with each treatment.
Eligibility and Details: Investigators are seeking participants aged 18 to 55 who have experienced at least two relapses that have been medically documented within the last three years, with one occurring in the last 12 months.
Participants will be randomly assigned to one of three groups, for a study period of approximately two years and three months:
• BIIB017 125 mg delivered subcutaneously (under the skin) every two weeks
• BIIB017 125 mg delivered subcutaneously every four weeks
The primary objective of the study is to determine the effects of the drug versus placebo on the annualized relapse rate. Secondary objectives include the effects on tissue damage as observed on MRI scans, quality of life, and disease progression as measured by the EDSS scale.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email ADVANCEStudy@biogenidec.com. As of now, sites are located in the following cities in the United States:
St Petersburg, FL
Round Rock, TX
To download a brochure discussing issues to think about when considering enrolling in an MS clinical trial (PDF), see the trial listing at the National MS Society site.