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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ClinicalTrials.gov Identifier: NCT00424788 |
Recruitment Status :
Completed
First Posted : January 22, 2007
Last Update Posted : September 4, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing Forms of Multiple Sclerosis | Procedure: Plasma exchange Drug: natalizumab treatment | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS) |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |


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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424788
United States, Ohio | |
Cleveland Clinic Mellen Center for MS | |
Cleveland, Ohio, United States, 44195 | |
United States, Wisconsin | |
Center for Neurological Disorders, Aurora Health Care | |
Milwaukee, Wisconsin, United States, 53201-0342 |
Study Director: | Michael Panzara, MD MPH | Biogen |
ClinicalTrials.gov Identifier: | NCT00424788 |
Other Study ID Numbers: |
101MS001 |
First Posted: | January 22, 2007 Key Record Dates |
Last Update Posted: | September 4, 2009 |
Last Verified: | September 2009 |
multiple sclerosis (MS) |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Natalizumab Immunologic Factors Physiological Effects of Drugs |