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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00424788 |
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Date of registration:
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18/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
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Scientific title:
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A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS) |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00424788 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Panzara, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen Idec |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- considered by the Investigator to be free of signs and symptoms suggestive of any
serious opportunistic infection
- willing to discontinue and remain free from concomitant immunosuppressive or
immunomodulatory treatment (including interferon beta and glatiramer acetate) for the
duration of the study
- willing and able to comply with the site's plasma exchange protocol which may require
hospitalization or daily visits
Exclusion Criteria:
- considered by the Investigator to be immunocompromised
- history of, or available abnormal laboratory results indicative of any major disease
that would preclude the administration of a recombinant humanized antibody
immunomodulating agent for the duration of the study.
- condition(s) considered to be contraindication(s) for plasma exchange, including but
not limited to bleeding diathesis, hypotension, or vascular access limitations
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Relapsing Forms of Multiple Sclerosis
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Intervention(s)
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Procedure: Plasma exchange
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Drug: natalizumab treatment
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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