Compares CT-P53 with Ocrevus in relapsing-remitting multiple sclerosis
Tests CT-P53 against Ocrevus in adults with relapsing-remitting multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
Key facts
- Where
- Poznan, PolandSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT05906992, who can take part
Where in Poland
- PoznanPoznan, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celltrion
- Trial code
- NCT05906992
- Record updated
- 22 May 2024
- Original description
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.Read full original descriptionShow less
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
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.
Inclusion: 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.
Exclusion: Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol; 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; 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.