Primary Objective: * To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis. Secondary Objectives: * To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis. * To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
The duration of study per patient will be approximately 61 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:solution for infusion Route of administration: intravenous
Pharmaceutical form:injection Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 724001
Barcelona, Spain
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
Change from baseline in lymphocyte subsets after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
Change from baseline in total lymphocyte count after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
Change from baseline in helper/suppressor ratio after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax)
Time frame: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax)
Time frame: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration versus time curve from time zero until the last measurable concentration (AUClast)
Time frame: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC)
Time frame: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z)
Time frame: 30 days after each treatment course
Number of patients with adverse events
Time frame: 4 years
Number of patients with adverse events of special interest
Time frame: 4 years
Number of patients with injection site reactions
Time frame: 2 years
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