A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
Phase 1
Completed
- Conditions
- Progressive Multiple Sclerosis
- Interventions
- Registration Number
- NCT02583594
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
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.
- Detailed Description
The duration of study per patient will be approximately 61 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description alemtuzumab (intravenous infusion) alemtuzumab GZ402673 Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Ceterizine Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) alemtuzumab GZ402673 Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Ceterizine Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Acyclovir Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Loratadine Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Methylprednisolone Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Paracetamol Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Acyclovir Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Methylprednisolone Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Paracetamol Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Loratadine Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (subcutaneous injection) Dexchlorpheniramine Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. alemtuzumab (intravenous infusion) Dexchlorpheniramine Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration.
- Primary Outcome Measures
Name Time Method Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration Baseline, 30 days after each treatment course
- Secondary Outcome Measures
Name Time Method Number of patients with injection site reactions 2 years Change from baseline in helper/suppressor ratio after alemtuzumab administration Baseline, 30 days after each treatment course Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax) 30 days after each treatment course Change from baseline in lymphocyte subsets after alemtuzumab administration Baseline, 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) 30 days after each treatment course Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z) 30 days after each treatment course Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC) 30 days after each treatment course Number of patients with adverse events of special interest 4 years Change from baseline in total lymphocyte count after alemtuzumab administration Baseline, 30 days after each treatment course Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax) 30 days after each treatment course Number of patients with adverse events 4 years
Trial Locations
- Locations (1)
Investigational Site Number 724001
🇪🇸Barcelona, Spain