Health Condition 1: G311- Senile degeneration of brain, notelsewhere classified
Conditions
Interventions
Intervention1: MIT-004
(Ocrelizumab)
: concentrate for preparing an infusion solution, 30 mg/ml in patients with multiple sclerosis
Control Intervention1: Ocrevus (Ocrelizumab)
: concentrate for prepa
Sponsors
MEDICAL INNOVATIONS AND TECHNOLOGIES (LLC MIT)
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed and dated Informed Consent of the patient to participate in the study 2.Male and female patients aged 18-55 years old 3.Diagnosis of multiple sclerosis established according to the McDonald criteria (2017) 4.Presence of a relapsing form of multiple sclerosis with active disease. 5.Patients recommended for starting ocrelizumab therapy and who have not previously received ocrelizumab 6.Patients EDSS severity 0-5.5 points 7.Compliance with established contraception rules
Exclusion criteria
Exclusion criteria: 1.Withdrawal of informed consent by the patient 2.The Investigator decided that the patient should be excluded in the best interests of the patient himself 3.The patient has experienced an undesirable phenomenon or a serious undesirable phenomenon, which, in the investigators opinion, makes it dangerous for the patient to continue participating in the study 4.Patients failure to comply with the rules of participation in the study. 5.The patient was included in violation of the inclusion/non-inclusion criteria of the protocol 6.The need to prescribe therapy prohibited by the Study Protocol 7.Pregnancy of the study participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve after Infusion 1 (Day 1 15) and Infusion 2 (Day 15 141)Timepoint: Day 1 - before the infusion, 0.5 h, 1.5 h, 3 h, 6 h, 12 h after the start of the infusion, Day 2 24 hours after the start of the infusion, Days 3 (48h), 4 (72h), 5 (96h), 7 (144 h), 9 (192h), 12 (264h), 15 (336h) (before infusion 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity assessment determining binding and neutralizing antibodies to ocrelizumabTimepoint: visit 9, visit 25 compared to the data obtained at visit 1.;Pharmacodynamic assessment Dynamics of CD19 levelsTimepoint: visits 9 and 25 compared to data obtained at visit 0 (Screening visit) | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Sayali Sadgune
Mudra Clincare
Outcome results
None listed