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NCT00536120 · ClinicalTrials.gov registry record · Phase 4
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
A Phase 4 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00536120 is a Phase 4 study that has completed, run by Biogen. The registered enrollment target is 60 participants.
The verdict
NCT00536120, a Phase 4 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[KLH\]) and a recall antigen (tetanus toxoid \[Td\]), and to evaluate the effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.
Interventions
- BIOLOGICAL BG00002 (natalizumab)
- BIOLOGICAL keyhole limpet hemocyanin (KLH)
- BIOLOGICAL tetanus diphtheria toxoid vaccine (Td)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00536120
The ClinicalTrials.gov registry entry for NCT00536120 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BG00002 (natalizumab) is the first listed.
NCT00536120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00536120 about?
NCT00536120 is a clinical study titled "The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis". The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[KLH\]) and a recall antigen (tetanus toxoid \[Td\]), and to evaluate the effect of Tysabri on circulating lymphocyte sub...
What is the current status of trial NCT00536120?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2008-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00536120?
The interventions under investigation include: BG00002 (natalizumab) (BIOLOGICAL), keyhole limpet hemocyanin (KLH) (BIOLOGICAL), tetanus diphtheria toxoid vaccine (Td) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00536120?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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