Combination Therapy With Avonex and BiMonthly High Dose Intravenous Me
An Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 22 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Methotrexate
Dihydrofolate reductase inhibitor
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.
Papers
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History
Started
Jul 2001
Main results due
Dec 2003
Finished
Dec 2003