Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00516893 | Natalizumab High Titer Immunogenicity and Safety | PHASE2 | COMPLETED | 113 | — | — | Oct 1, 2006 | Dec 1, 2007 | May 15, 2014 | 13 | United States |
Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.
| Arm | Type | Description |
|---|---|---|
| Natalizumab High Titer | EXPERIMENTAL | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
| Name | Type | Description |
|---|---|---|
| BG00002-E (natalizumab high titer) | BIOLOGICAL | - |
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 t...