Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Multiple Sclerosis
  • Primary Progressive Multiple Sclerosis
  • Relapse
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The first dose of ocrelizumab will be administered as two 300-mg IV infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15), followed by one 600-mg IV infusion in 500 mL 0.9% sodium chloride every subsequent doses (i.e., every 24 weeks) for 72 weeks.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

The first dose of ocrelizumab will be administered as two 300-mg IV infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15), followed by one 600-mg IV infusion in 500 mL 0.9% sodium chloride every subsequent doses (i.e., every 24 weeks) for 72 weeks. P...

The first dose of ocrelizumab will be administered as two 300-mg IV infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15), followed by one 600-mg IV infusion in 500 mL 0.9% sodium chloride every subsequent doses (i.e., every 24 weeks) for 72 weeks. Premedication with 100 mg of methylprednisolone (or an equivalent) approximately 30 minutes prior to each ocrelizumab infusion and additional premedication with an antihistaminic drug (e.g., diphenhydramine) approximately 30 - 60 minutes before each infusion of ocrelizumab to reduce the frequency and severity of infusion-related reactions (IRRs). The addition of an antipyretic (e.g., acetaminophen/ paracetamol) may also be considered. Patients will undergo PET scan with 18F-DPA714 and MRI exams at different time points as mentioned in the assessment table. Disease will be clinically monitored at different time points with classical tests including EDSS, MSFC, BICAMS. Laboratory analyses on complete blood count, lymphocytes subsets count, neurofilament will be done. Analyses will not be limited to the above mentioned list. Pregnancy tests and genetics will be done. An optional lumbar puncture will be performed at baseline to assess cytokinic profile predictive of disease evolution and cortical pathology. Patients who refuse to have a lumbar puncture can be included in the clinical trial if they have eligibility criteria. TSPO polymorphism will be checked at baseline with other screening lab tests.

Tracking Information

NCT #
NCT03691077
Collaborators
  • Roche Pharma AG
  • Institut du Cerveau et de la Moelle épinière
Investigators
Principal Investigator: Bruno Stankoff, MD Ph.D Hôpital Saint-Antoine - Service de Neurologie