A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)
- Conditions
- demyelinating diseaseMultiple sclerosis10012303
- Registration Number
- NL-OMON49585
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 1
-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.
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of new or enlarging T2 lesions on brain MRI, during continuation of<br /><br>prior DMT (Period 1) compared to an equal period after the first course of<br /><br>alemtuzumab treatment (Period 2).</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Number of patients with new or enlarging T2 lesions during continuation of<br /><br>prior DMT (Period 1) compared to an equal period after the first course of<br /><br>alemtuzumab treatment (Period 2)<br /><br>* Annualized relapse rate<br /><br>* Assessment of cognition test scores through Brief Visuospatial Memory Test<br /><br>* Assessment of generic pediatric QoL measures<br /><br>* Assessment of PK parameters<br /><br>* Assessment of PD parameter<br /><br>* Number of patients with adverse events<br /><br>* Assessment of development of anti-alemtuzumab antibodies</p><br>