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Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis Clinical research trials and Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis. Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis clinical trial. Human subjects often get the best healthcare possible for their Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis  Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: No longer recruiting
Sponsor(s): MidAmerica Neuroscience Institute , Consultants in Neurology,Biogen Idec
Synopsis: The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment: - Between the ages of 18 and 60 years, inclusive. - Diagnosis of clinically definite relapsing MS. - Must have been on AVONEX® therapy for at least six months. - Brain MRI scans demonstrating lesions consistent with MS. - Subject must have had at least one clinical exacerbation in the last year, and this must have occurred after having been on AVONEX® therapy for at least six to twelve (6-12) months. A clinical exacerbation is defined as a decrease of 0.1 in the MSFC composite or any of the subset domains scores administered 3 months apart. - Give written informed consent prior to any testing under this protocol, including screening tests and evaluation that are not considered part of the subject's routine care. To be eligible for treatment with methotrexate, subjects must have evidence for MS disease activity on their baseline screening MRI.
Total Enrollment: 15
Location and Contact Information:
MidAmerica Neuroscience Institute
Kansas City, Missouri, 64108
United States
Additional Information:
Study ID Numbers: MANI-MTX01-001;
Study Start Date: July 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037102
Other Multiple Sclerosis Studies:
1. Safety, Tolerability, and Effectiveness of CGP77116 in Patients with Multiple Sclerosis (MS)
2. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
3. A study to evaluate the preliminary efficacy pharmacokinetics and immunogenicity of BMS-188667 administered to subjects with relapsing-remitting multiple sclerosis
4. Antibiotic treatment trial directed against Chlamydia pneumonia in multiple sclerosis
5. Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
Related Studies:
Other Multiple Sclerosis Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
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