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Sponsors and Collaborators: |
MidAmerica Neuroscience Institute Consultants in Neurology Biogen Idec |
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Information provided by: | MidAmerica Neuroscience Institute |
ClinicalTrials.gov Identifier: | NCT00037102 |
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: interferon beta 1a Drug: methotrexate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | December 2003 |
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue. Entrance into the study will be based on Multiple Sclerosis Functional Composite Score (MSFC) evaluations at –4 months, and - 1 month prior to study, where a decrease in score is noted. The composite score consists of the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test 3 (PASAT 3). The patient must have been on AVONEX® for at least 6 months.
At study entrance, baseline lab work (complete blood count, platelet count, routine electrolytes, blood urea nitrogen, creatinine, liver function tests, 24 hour urine collection for creatinine clearance, and urine pH), an electrocardiogram (measurement of heart activity) and serum pregnancy test will be done. A complete physical examination will be performed, including measurements of vital signs (heart rate and blood pressure), as well as magnetic resonance imaging (MRI) to document status of disease. A self-administered questionnaire, the MSQLI (Multiple Sclerosis Quality of Life Instrument), will be completed at baseline and at the end of the study. MSFC and safety evaluations (previously mentioned blood and urine tests and electrocardiograms (EKG), will be conducted throughout the study at months 2, 4, 6, 8, 10, and 12. Blood tests of immune cells will also be drawn at these visits. The patient can continue this regimen of treatment at their own discretion and cost, and outside the parameters of this study, if there is apparent efficacy without serious adverse events. This treatment would be under the supervision of Dr. Rowe.
The patients will continue their AVONEX® intramuscular injections of 30 micrograms (administered by patient or caregiver) on a weekly basis with scheduled intravenous high dose methotrexate at 2 Gm/m2 followed by intravenous and oral leucovorin rescue once every 2 months. The methotrexate infusions will be performed in our outpatient infusion center. The patient will be required to complete a patient diary during the course of the trial, participate in and keep all scheduled appointments, and to inform the research staff and physician of any change in concomitant medications or adverse events that they may experience.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment:
To be eligible for treatment with methotrexate, subjects must have evidence for MS disease activity on their baseline screening MRI.
Study ID Numbers: | MANI-MTX01-001 |
Study First Received: | May 15, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00037102 |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Relapsing Methotrexate AVONEX |
interferon beta 1a demyelinating autoimmune |
Autoimmune Diseases Demyelinating Diseases Interferons Interferon-beta Leucovorin Sclerosis Demyelinating diseases |
Folic Acid Multiple Sclerosis Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Methotrexate Autoimmune Diseases of the Nervous System |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Adjuvants, Immunologic Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |