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CompletedNCT00424788Updated Sep 4, 2009

A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)

An Early Phase 1 interventional study of Plasma exchange and natalizumab treatment in Relapsing Forms of Multiple Sclerosis, sponsored by Biogen. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-09-04.

Sponsored by Biogen · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or eliminated by separating and removing the plasma and replacing it with other fluids, a process called plasma exchange.

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Conditions studied

  • Relapsing Forms of Multiple Sclerosis

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Keywords

  • multiple sclerosis (MS)
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

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Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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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

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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • ProcedurePlasma exchange
  • Drugnatalizumab treatment
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Study locations

2 sites
  • Cleveland Clinic Mellen Center for MS
    Cleveland, Ohio 44195, United States
  • Center for Neurological Disorders, Aurora Health Care
    Milwaukee, Wisconsin 53201-0342, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00424788
Lead sponsor
Biogen
First posted
Jan 22, 2007
Start date
Jan 2007
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Sep 4, 2009

Study contacts

Michael Panzara, MD MPH
study director · Biogen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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