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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003265-19 | EudraCT Number | ||
| U1111-1160-6120 | Other Identifier | UTN |
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Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
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Primary Objective:
To assess the long-term safety of vatelizumab in MS patients
Secondary Objective:
To assess the long-term efficacy of vatelizumab
The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vatelizumab Dose 1 | Experimental | Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks |
|
| Vatelizumab Dose 2 | Experimental | Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks |
|
| Vatelizumab Dose 3 | Experimental | Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks |
|
| Vatelizumab Dose 4 | Experimental | Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vatelizumab | Drug | Pharmaceutical form:solution for infusion Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing adverse events | from Week 0 to Week 192 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total volume of T2 lesions | from Week 0 to Week 84 | |
| Change in number of T1 hypointense lesions | from Week 0 to Week 84 |
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Inclusion criteria:
Patients who completed the 12-week treatment period in DRI13839.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840004 | Cullman | Alabama | 35058 | United States | ||
| Investigational Site Number 840005 |
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|
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Investigational Site Number 840007 | Ormond Beach | Florida | 32174 | United States |
| Investigational Site Number 840001 | Latham | New York | 12210 | United States |
| Investigational Site Number 840003 | Round Rock | Texas | 78681 | United States |
| Investigational Site Number 840016 | San Antonio | Texas | 78258 | United States |
| Investigational Site Number 124001 | Greenfield Park | J4V 2J2 | Canada |
| Investigational Site Number 616001 | Lodz | 93-121 | Poland |
| Investigational Site Number 616004 | Lublin | 20-090 | Poland |
| Investigational Site Number 616003 | Lublin | 20-718 | Poland |
| Investigational Site Number 616002 | Szczecin | 70-215 | Poland |
| Investigational Site Number 643010 | Kazan' | 420021 | Russia |
| Investigational Site Number 643009 | Moscow | 107150 | Russia |
| Investigational Site Number 643006 | Nizhny Novgorod | 603076 | Russia |
| Investigational Site Number 643005 | Nizhny Novgorod | 603155 | Russia |
| Investigational Site Number 643008 | Novosibirsk | 630087 | Russia |
| Investigational Site Number 643002 | Saint Petersburg | 197089 | Russia |
| Investigational Site Number 643001 | Saint Petersburg | 197376 | Russia |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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