Phase 3
Completed N=1,094
Natalizumab Re-Initiation of Dosing
Multiple Sclerosis, Relapsing-Remitting
Source: ClinicalTrials.gov NCT00306592 ↗
Enrolled (actual)
1,094
Serious AEs
5.6%
Results posted
Jan 2010
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs) — 826; 487; 66; 161 participants
Summary
The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs) |
826; 487; 66; 161; 61; 5 | — |
| PRIMARY Number of Participants With Hypersensitivity-related Adverse Events |
8 | — |
| PRIMARY Number of Participants With Antibodies to Natalizumab |
1004; 15; 8; 16 | — |
Eligibility Criteria
Inclusion Criteria
- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging [MRI] scan)
- Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used)
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
- History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00306592). 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.