Natalizumab High Titer Immunogenicity and Safety
A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
Results by group
Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status
Assessed every 12 weeks from Week 0 (Baseline) to Week 36
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Natalizumab High Titer | 96 participants | 108 | |
| Natalizumab High Titer | 3 participants | 108 | |
| Natalizumab High Titer | 9 participants | 108 |
Natalizumab High Titer
Natalizumab High Titer
Natalizumab High Titer
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Natalizumab High Titer | 112 | 7 (6.3%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status
Assessed every 12 weeks from Week 0 (Baseline) to Week 36
Other measures (3)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.
SafetyMean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36
Baseline, Week 36
Disability progressionAnnualized Relapse Rate
Through Week 36
Relapses
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* Diagnosis of a relapsing form of MS * Must fall within the therapeutic indications stated in the locally approved label for natalizumab * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Prior treatment with natalizumab * Considered by investigator to be immunocompromised * Other protocol-defined exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.
Papers
Loading reviews and guidelines…
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History
Started
Oct 2006
Main results due
Oct 2007
Finished
Dec 2007
Results posted
Aug 2009