demyelinating disease Multiple sclerosis
Conditions
Interventions
Two doses of intravenous (IV) infusion of alemtuzumab.
Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5
consecutive days, followed by Dose 2 (second course) on 3 consec
Children
Efficacy
Multiple sclerosis
Sponsors
Sanofi-aventis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: -Patients with RRMS aged from 10 years to less than 18 years at study entry are eligible. Patients must meet the criteria of diagnosis of MS as defined by the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on McDonald criteria 2010. -Signed informed consent/assent obtained from patient and patient*s legal representative (parent or guardian) according to local regulations. -Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening. -At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a interferon-beta (IFNB) or glatiramer acetate (GA) after having been on that therapy for at least 6 months -At least 1 of the following: -*1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion* while on that same prior therapy (IFNB or GA), OR -Two or more relapses in the prior year, OR -Tried at least 2 MS DMTs.
Exclusion criteria
Exclusion criteria: -Any prior exposure to alemtuzumab. -Any progressive or nonrelapsing form of MS. -Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months, or as determined by the treating physician to have residual immune suppression from these or other MS treatments. -Treatment with teriflunomide in the last 12 months except if the patient underwent the accelerated elimination procedure as per local teriflunomide label. -Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide or any cytotoxic therapy. -CD4+, CD8+, or CD19+ absolute cell count in blood at screening below lower limit of normal (LLN). -Prior documented history of thrombocytopenia, or platelet count at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of new or enlarging T2 lesions on brain MRI, during continuation of prior DMT (Period 1) compared to an equal period after the first course of alemtuzumab treatment (Period 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Number of patients with new or enlarging T2 lesions during continuation of prior DMT (Period 1) compared to an equal period after the first course of alemtuzumab treatment (Period 2) * Annualized relapse rate * Assessment of cognition test scores through Brief Visuospatial Memory Test * Assessment of generic pediatric QoL measures * Assessment of PK parameters * Assessment of PD parameter * Number of patients with adverse events * Assessment of development of anti-alemtuzumab antibodies | — |
Countries
Austria, Belgium, Bulgaria, France, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Switzerland, Turkey, United Kingdom
Outcome results
None listed