Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037115
Status:
WITHDRAWN
Last Update Posted:
2018-04-12
First Post:
2002-05-15
Brief Title:
Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue Prior to Initiation of AVONEX Treatment in Patients Presenting With a First Acute Demyelinating Event
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 Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue Prior to Initiation of AVONEX Treatment in Patients Presenting With a First Acute Demyelinating Event Comparison With CHAMPS Results
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The participant will receive weekly intramuscular treatment with AVONEX interferon beta 1-a and a one-time high dose intravenous methotrexate with Leucovorin rescue along with the standard solumedrol treatment before beginning AVONEX treatment
Detailed Description:
The participant will receive weekly intramuscular treatment with AVONEX interferon beta 1-a and a one-time high dose intravenous methotrexate with Leucovorin rescue along with the standard solumedrol treatment before beginning AVONEX treatment
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 urine pregnancy test urinalysis and urine culture and sensitivity if needed and an electrocardiogram measurement of heart activity will be done A complete medical history neurological and opthamological examination will be performed including measurements of vital signs heart rate and blood pressure as well as magnetic resonance imaging MRI EDSS and Visual Evoked Response test VERs to document status of disease A Multiple Sclerosis Functional Composite Score MSFC consists of the Timed 25 Foot Walk Nine Hole Peg Test 9HPT and Paced Auditory Serial Addition Test 3 PASAT3 will be performed at screen as well At months 6 12 18 24 30 and 36 the tests and evaluations will include MRI MSFC VERs and blood tests of immune cells Other safety evaluations previously mentioned blood and urine tests will be conducted according to the date of treatment These tests include a laboratory test methotrexate level two days following treatment as well as routine lab tests 2 weeks following the methotrexate treatment 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 The methylprednisolone treatment and methotrexate infusion 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 urine pregnancy test urinalysis and urine culture and sensitivity if needed and an electrocardiogram measurement of heart activity will be done A complete medical history neurological and opthamological examination will be performed including measurements of vital signs heart rate and blood pressure as well as magnetic resonance imaging MRI EDSS and Visual Evoked Response test VERs to document status of disease A Multiple Sclerosis Functional Composite Score MSFC consists of the Timed 25 Foot Walk Nine Hole Peg Test 9HPT and Paced Auditory Serial Addition Test 3 PASAT3 will be performed at screen as well At months 6 12 18 24 30 and 36 the tests and evaluations will include MRI MSFC VERs and blood tests of immune cells Other safety evaluations previously mentioned blood and urine tests will be conducted according to the date of treatment These tests include a laboratory test methotrexate level two days following treatment as well as routine lab tests 2 weeks following the methotrexate treatment 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 The methylprednisolone treatment and methotrexate infusion 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