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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03689972 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration | PHASE3 | COMPLETED | 585 | — | — | Nov 27, 2018 | Jul 24, 2023 | Jun 12, 2024 | 107 | United States, Australia +9 |
| NCT00030966 | Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis | PHASE3 | COMPLETED | 1,200 | — | — | Jan 1, 2002 | Dec 1, 2005 | Jun 18, 2009 | 88 | United States, Austria +5 |
| NCT00027300 | Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis | PHASE3 | COMPLETED | 900 | — | — | Nov 1, 2001 | Jan 1, 2005 | Jan 9, 2017 | 53 | United States, Belgium +6 |
| NCT00097760 | Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis | PHASE2 | COMPLETED | 110 | — | — | Jun 1, 2003 | Mar 1, 2004 | Jun 18, 2009 | - | — |
T2 hyperintense lesions were analyzed by magnetic resonance imaging (MRI) scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new or newly enlarging T2 hyperintense lesions at Week 72 relative to baseline.
| Arm | Type | Description |
|---|---|---|
| Part 1: IV Q4W | EXPERIMENTAL | Participants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72. |
| Part 1: IV Q6W | EXPERIMENTAL | Participants received natalizumab 300 mg IV infusion once Q6W up to Week 72. |
| Part 2: Run-in Period: IV Q6W | EXPERIMENTAL | Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102. |
| Part 2: Crossover Period: IV Q6W, then SC Q6W | EXPERIMENTAL | Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg IV infusion Q6W from Week 108 through Week 126 followed by natalizumab 300 mg subcutaneous (SC) injection Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156. |
| Part 2: Crossover Period: SC Q6W, then IV Q6W | EXPERIMENTAL | Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg SC injection Q6W from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156. |
| Group 1 | EXPERIMENTAL | Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks. |
| Group 2 | PLACEBO_COMPARATOR | Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks. |
| Name | Type | Description |
|---|---|---|
| Natalizumab | DRUG | Natalizumab 300 mg IV infusion. |
| Placebo | DRUG | Placebo monthly infusion for up to 116 weeks. |
Key Inclusion Criteria: For Part 1: * Ability of the participant to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * Diagnosi...