IRB Number:

157-05

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

The purpose of this research study is to determine whether the combination of interferon beta 1-a (Avonex®) and glatiramer acetate (Copaxone®) is an effective therapy for Relapsing-Remitting form of Multiple Sclerosis (MS).

Sponsored by the National Institutes of Health-National Institute of Neurological Disorders and Stroke (NIH-NINDS), the study, known as CombiRx, will determine if the combined use of each treatment reduces relapse rate when compared to either agent alone.

An estimated 400,000 Americans suffer from MS, a chronic neurological disease that affects the central nervous system. MS is most commonly diagnosed in young adults. Relapsing-remitting MS, the most common form of new cases of the disease, is characterized by episodes of attacks of neurologic dysfunction, which occur over many years.

Who is Eligible to Participate in the Study?

People eligible for participation must meet the following criteria:

• Men and women 18-60 years of age


• Patient has been diagnosed with Relapsing Remitting Multiple Sclerosis


• Patient is not pregnant, breast-feeding or planning to become pregnant


• Patient has not had previous treatment with interferon-1a or glatiramer acetate


• Patient is not in any other experimental clinical trial


• Patient has no history of any significant cardiac, hepatic, pulmonary, renal-disease or immune deficiency.

Minimum Age:

18

Maximum Age:

60

What is Involved With this Study?

Your consent to participate in this study means that you agree to be treated as described and that you may need to undergo tests, procedures, and examinations not routinely required in your treatment of MS.

You will be put in one of 3 groups by chance. You and your study doctor will not know which group you have been placed into. You will receive two different types of injections. Each injection will contain the active drug or placebo.

The 3 groups are as follows:

• Interferon beta-1a and placebo


• Glatiramer acetate and placebo


• Interferon beta-1a and glatiramer acetate

There is a 25% chance of being assigned to the first group; a 25% chance of being assigned to the second group; and a 50% chance of being assigned to the third group.

How long will the Study run?

Participants will be enrolled in this research study for up to 36 months.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact:

Mayo Clinic Arizona - (480) 301-8788
Mayo Clinic Rochester - (507) 284-9360

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Scottsdale and Phoenix, AZ

Last updated: 09/17/2007