Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

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

Detailed description: 
      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.
    

Intervention name(s): interferon beta 1a; methotrexate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing; Methotrexate; AVONEX; interferon beta 1a; demyelinating; autoimmune