Relapsing-remitting multiple sclerosis MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Genzyme GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -A patient with RRMS who has received two courses of alemtuzumab and has an active disease defined by clinical or imaging features. -Patients with at least 1 relapse within 12 months prior to screening. -Signed written consent form. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients who have any of the contraindications noted in the Summary of Product Characteristics (SmPC) of alemtuzumab. -Patients who received previously more than 2 courses alemtuzumab. -Patients have received and/or have been receiving any disease modifying MS treatment (excluding corticosteroids) after the second and before the planned additional course of alemtuzumab. -Patients who received alemtuzumab within less than last 12 months. -Patients, who are unwilling or unable to complete the questionnaires being used in the study. -Patients, who are currently participating in an investigational interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of effectiveness of an additional alemtuzumab course in patients with relapsing remitting multiple sclerosis (RRMS) with disease activity after 2 courses.; Secondary Objective: -To assess changes over time in: -Expanded Disability Status Scale (EDSS) scores, -Magnetic resonance imaging (MRI) lesions (Gd and T2 lesions), -Symbol Digit Modalities Test (SDMT), -Patient Reported Indices for Multiple Sclerosis (PRIMUS), -Euro Quality of Life (EuroQoL, EQ-5D) score, -Work Productivity and Activity Impairment (WPAI) at each visit compared to baseline score. -To describe the safety and tolerability of alemtuzumab after an additional treatment course. ; Primary end point(s): - Change in neurological examination (Confirmed relapse[s]) - Changes from baseline in EDDS score (increase of at least 1 point) ; Timepoint(s) of evaluation of this end point: add 1: Visit V3 (Month 6) and V4 (Month 12 – End Of Study) add 2: 12 months following the 3 Day course of alemtuzumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-3: V4 (Month 12 – End Of Study) 4-8: Visit V3 (Month 6) and V4 (Month 12 – End Of Study) 9: Up to Month 12 (V4) ; Secondary end point(s): 1. Percentage of relapse-free participants 2. Percentage of participants with active MRI lesions 3. Change in number of active MRI lesions (Gd and T2 lesions) 4. Change over time in Expanded Disability Status Scale (EDSS) 5. Change over time in Symbol Digit Modality Test (SDMT) 6. Change over time in Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS) 7. Change over time in Euro Quality of Life (EQ-5D) 8. Change over time in Work Productivity and Activity Impairement Questionnaire (WPAI) 9. Number of participants with adverse events | — |
Countries
Germany
Outcome results
None listed