Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Biogen.
NCT00536120 is a Phase 4 study that has completed, run by Biogen. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.
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 |
What the finished NCT00536120 record still lists
NCT00536120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which BG00002 (natalizumab) is the first listed.
NCT00536120 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00536120's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia