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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]:
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 |
| Health Authority: | United States: Food and Drug Administration |
|
Neuritis Optic Neuritis Demyelinating Multiple Sclerosis Myelitis AVONEX methotrexate methylprednisolone |
interferon beta 1a demyelination central nervous system brain nerve lesions enhancement enhancing |
|
Papillitis Spinal Cord Diseases Methylprednisolone Leucovorin Prednisolone acetate Demyelinating diseases Neuritis Multiple Sclerosis Neuromuscular Diseases Interferon beta 1a Methotrexate Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate Optic Neuritis Autoimmune Diseases |
Demyelinating Diseases Eye Diseases Interferons Interferon-beta Methylprednisolone acetate Central Nervous System Diseases Sclerosis Optic nerve disorder Folic Acid Virus Diseases Central Nervous System Infections Peripheral Nervous System Diseases Prednisolone Demyelinating Autoimmune Diseases, CNS Myelitis |
|
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Central Nervous System Viral Diseases Reproductive Control Agents Hormones Neuroprotective Agents Pathologic Processes |
Therapeutic Uses Abortifacient Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Hormonal Immune System Diseases Nervous System Diseases Adjuvants, Immunologic Gastrointestinal Agents Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Glucocorticoids Protective Agents Antiviral Agents |
