A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT05906992
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
512 participants
INTERVENTIONAL
2024-01-11
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P53
CT-P53(Ocrelizumab)
CT-P53
Intravenous(IV) infusion
US-Ocrevus
US-licensed Ocrevus(Ocrelizumab)
US-Ocrevus
Intravenous(IV) infusion
EU-Ocrevus
EU-approved Ocrevus(Ocrelizumab)
EU-Ocrevus
Intravenous(IV) infusion
Interventions
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CT-P53
Intravenous(IV) infusion
US-Ocrevus
Intravenous(IV) infusion
EU-Ocrevus
Intravenous(IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
* Patient who has currently or history of any of medical conditions described in the study protocol.
* Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
18 Years
55 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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Minji Ma
Role: STUDY_CHAIR
Celltrion, Inc.
Locations
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CT-P53 3.1 investigational site
Poznan, , Poland
Countries
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Central Contacts
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Other Identifiers
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CT-P53 3.1
Identifier Type: -
Identifier Source: org_study_id
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