Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037102
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2002-05-15
Brief Title:
Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
Sponsor:
MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Organization:
MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTX01
Brief 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 Gmm2 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
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 Gmm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None