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|NCT03368664 : A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT|
|Ages||Min: 10 Years Max: 17 Years|
Inclusion criteria :
- Patients with Relapsing Remitting Multiple Sclerosis (RRMS) aged from 10 years to less
than 18 years at study entry are eligible. Patients should meet the criteria of
diagnosis of Multiple Sclerosis as defined by the International Pediatric Multiple
Sclerosis Study Group (IPMSSG) criteria for pediatric Multiple Sclerosis (MS) and the
criteria of Multiple Sclerosis (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 Multiple Sclerosis (MS) attacks and at least 1 Multiple Sclerosis
(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 Multiple Sclerosis Disease Modifying Therapies (DMTs).
- Any progressive or non-relapsing forms of MS.
- Conditions/situations such as:
- Impossibility to meet specific protocol requirements.
- Current participation in another interventional clinical 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
- Uncooperative patient or any condition that could make the patient potentially
non-compliant to the study procedures in the opinion of the Investigator.
- Mental condition rendering the patient or parent/guardian unable to understand the
nature, scope, and possible consequences of the study.
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
systemic disease making implementation of the protocol or interpretation of the study
results difficult or that would put the patient at risk by participating in the study
in the opinion of the Investigator.
- History of drug or alcohol abuse.
- History of known human immunodeficiency virus (HIV) positivity.
- Pregnant or breast-feeding female patients or those who plan to become pregnant during
- Unwilling to agree to use a reliable and effective contraceptive method as defined for
contraception in the Informed Consent form (ICF) when receiving a course of
alemtuzumab treatment and for 4 months following that course of treatment (fertile
- Female patients who have commenced menstruating (ie, are of childbearing potential)
and are unwilling or unable to be tested for pregnancy.
- Previous treatment with alemtuzumab.
- Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine,
cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or
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
recommended elimination procedure as per Summary of Product Characteristics (SmPC ).
- Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab,
ocrelizumab, leflunomide, or any cytotoxic therapy.
- Previous treatment with any investigational medication (drug that has not been
approved at any dose or for any indication). Use of an investigational medication that
was subsequently licensed and nonstandard use of a licensed medication (eg, using a
dose other than the dose that is stated in the licensed product labeling or using a
licensed therapy for an alternative indication) is not exclusionary. Prior treatment
with herbal medications or nutritional supplements is also permitted.
- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.
- History of malignancy.
- Prior documented history of thrombocytopenia, or platelet count at screening < lower
limits of normal (LLN).
- Any disability acquired from trauma or another illness that, in the opinion of the
Investigator, could interfere with evaluation of disability due to MS.
- Patients with known Type 1 hypersensitivity or anaphylactic reactions to the active
substances or any of the excipients, or intolerance of acyclovir or its therapeutic
- Major systemic disease or other illness that would, in the opinion of the
Investigator, compromise patient safety or interfere with the interpretation of study
results, eg, current peptic ulcer disease, or other conditions that may predispose to
hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus,
other connective tissue disorders, vasculitis, inflammatory bowel disease, severe
- Medical, psychiatric, cognitive, or other conditions that, in the Investigator's
opinion, compromise the patient's ability to understand the patient information, to
give informed consent, to comply with the trial protocol, or to complete the study.
- Major psychiatric disorder that is not adequately controlled by treatment in the
opinion of the Investigator.
- Epileptic seizures that are not adequately controlled by treatment.
- Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere
with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia,
orthopedic implants/treatments, orthodontic treatments etc).
- Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von
Willebrand's disease, disseminated intravascular coagulation [DIC], fibrinogen
deficiency, clotting factor deficiency).
- Prior history of invasive fungal infections.
- Active infection, eg, deep-tissue infection, that the Investigator considers
sufficiently serious to preclude study participation.
- In the Investigator's opinion, patient is at high risk for infection (eg, indwelling
catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration
pneumonia or recurrent urinary tract infection).
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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