Primary Objective: To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.
The total duration of participation in the study per patient is approximately 13.5 months. After the end of the second course of LEMTRADA treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 056002
Bruges, Belgium
Investigational Site Number 056001
Brussels, Belgium
Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion of IARs
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion and type of serious IARs
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
Proportion by type (as defined by clinical symptoms)
Time frame: up to 30 days in the first treatment course and the second treatment course, respectively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 250009
Dijon, France
Investigational Site Number 250005
Lille, France
Investigational Site Number 250001
Lyon Bron, France
Investigational Site Number 250006
Nancy, France
Investigational Site Number 250010
Nantes, France
Investigational Site Number 250007
Nîmes, France
Investigational Site Number 250008
Paris, France
Investigational Site Number 250004
Rennes, France
...and 10 more locations