Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
Phase 1
- Conditions
- Relapsing-remitting multiple sclerosisMedDRA version: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003265-19-PL
- Lead Sponsor
- Genzyme Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
Patients who completed the 12-week treatment period in DRI13839.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient’s participation in the long-term extension study.
Confirmed platelet count below the lower limit of normal at any time during DRI13839.
Pregnancy or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of vatelizumab in MS patients;Secondary Objective: To assess the long-term efficacy of vatelizumab;Primary end point(s): Number of treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: from Week 0 to Week 120
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in total volume of T2 lesions and number of T1 hypointense lesions<br>;Timepoint(s) of evaluation of this end point: Change in total volume of T2 lesions and number of T1 hypointense lesions : from Week 0 to Week 84<br>