Phase 2
Completed N=113
Natalizumab High Titer Immunogenicity and Safety
Source: ClinicalTrials.gov NCT00516893 ↗Enrolled (actual)
113
Serious AEs
6.3%
Results posted
Aug 2009
Primary outcomePrimary: Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status — 96; 3; 9 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status |
96; 3; 9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs |
106; 63; 18; 23; 7; 0 | — |
| SECONDARY Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36 |
-0.19 | — |
| SECONDARY Annualized Relapse Rate |
0.13 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00516893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.