Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
• Collaborators: Biogen; Consultants in Neurology
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Methotrexate

Criteria

To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment:

• Between the ages of 18 and 60 years, inclusive.

• Diagnosis of clinically definite relapsing MS.

• Must have been on AVONEX® therapy for at least six months.

• Brain MRI scans demonstrating lesions consistent with MS.

• Subject must have had at least one clinical exacerbation in the last year, and this must have occurred after having been on AVONEX® therapy for at least six to twelve (6-12) months. A clinical exacerbation is defined as a decrease of 0.1 in the MSFC composite or any of the subset domains scores administered 3 months apart.

• Give written informed consent prior to any testing under this protocol, including screening tests and evaluation that are not considered part of the subject's routine care.

To be eligible for treatment with methotrexate, subjects must have evidence for MS disease activity on their baseline screening MRI.