About this trial
This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.
Eligibility criteria
Qualifiers
Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
Patient has evidence of recent MS activity as defined in the study protocol
Patient has neurological stability for ≥30 days.
Patient with 0 to 6.0 (both inclusive) on the EDSS score.
Disqualifiers
Patient diagnosed with primary or secondary progressive MS.
Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
Patient unable to complete or has a contraindication to an MRI
Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
Trial design
Treatments tested in this trial
- CT-P53
- US-Ocrevus
- EU-Ocrevus