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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00262314 |
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prospective, Open-Label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients |
Enrollment: | 509 |
Study Start Date: | October 2000 |
Study Completion Date: | September 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years.
The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses).
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Male and female patients with a clinically definite or laboratory supported diagnosis of MS and having secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurologic status is significantly abnormal between relapses). Patients with primary progressive disease will not be included in this study.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | EMD Serono Inc. ( Jacqueline C. Beagan, RN, BSN ) |
Study ID Numbers: | 24293, 19-297 |
Study First Received: | December 5, 2005 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00262314 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Mitoxantrone Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |