Relapsing-remitting multiple sclerosis MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label - Signed written informed consent 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 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previously treated with Lemtrada - Contraindications to Lemtrada according to the labeling in the country - Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label - Currently participating in another investigational interventional study - Any technical/administrative reason that makes it impossible to enroll the patient in the study - Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol - Patient who has withdrawn consent before enrollment (starting from signed informed consent form) - Despite screening of the patient, enrolment is stopped at the study level - Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy - Pregnancy (defined as positive beta-HumanChorionicGonadotropin blood test), breast feeding - Known infection with latent tuberculosis or active Tuberculosis - Known infection with Hepatitis B, Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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;Secondary Objective: ;Primary end point(s): Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occuring during or within 24 hours of Lemtrada infusion. Proportion of IARs Proportion and type of serious IARs Proportion by type (as defined by clinical symptoms);Timepoint(s) of evaluation of this end point: up to 30 days in the first treatment course and the second treatment course, respectively | — |
Countries
Belgium, France, Netherlands, Spain, Switzerland
Contacts
Public ContactBrigitte De Witte
Sanofi Belgium
Outcome results
None listed