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| Sponsors and Collaborators: |
MidAmerica Neuroscience Institute Consultants in Neurology |
|---|---|
| Information provided by: | MidAmerica Neuroscience Institute |
| ClinicalTrials.gov Identifier: | NCT00037115 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Demyelinating Disorders Multiple Sclerosis Optic Neuritis Myelitis Neuritis |
Drug: interferon beta 1a Drug: methotrexate Drug: methylprednisolone |
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 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. |
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2002 |
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 (VER’s) 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, VER’s 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 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, which are the same as in the CHAMPS study [1]:
They must also have two or more clinically silent lesions of the brain that were at least 3 mm in diameter on MRI scans and were characteristic of MS (at least one lesion must be periventricular or ovoid).
Contacts and Locations More Information
| Study ID Numbers: | MANI-MTX02-001 |
| Study First Received: | May 15, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00037115 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Demyelinating Multiple Sclerosis Myelitis Neuritis Optic Neuritis AVONEX methotrexate methylprednisolone |
interferon beta 1a demyelination central nervous system brain nerve lesions enhancement enhancing |
|
Anti-Inflammatory Agents Papillitis Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neuromuscular Diseases Optic Nerve Disorder Interferon beta 1a Methotrexate Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate Demyelinating Diseases Antineoplastic Agents, Hormonal |
Interferon-beta Adjuvants, Immunologic Sclerosis Glucocorticoids Virus Diseases Folic Acid Demyelinating Autoimmune Diseases, CNS Optic Nerve Diseases Antimetabolites Spinal Cord Diseases Immunologic Factors Leucovorin Folate Prednisolone acetate Neuroprotective Agents |
|
Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Central Nervous System Viral Diseases Hormones Pathologic Processes Neuromuscular Diseases Therapeutic Uses Abortifacient Agents Interferon beta 1a |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Demyelinating Diseases Immune System Diseases Nervous System Diseases Adjuvants, Immunologic Interferon-beta Sclerosis Abortifacient Agents, Nonsteroidal Glucocorticoids Virus Diseases |
