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.
Key facts
- Where
- Bedzin, Gdansk, Katowice, Kielce, Łódź, Plewiska, Poznan, Szczecin, Warsaw, Zabrze és Zory, LengyelországSee the 16 sites
- Phase
- 3. fázis
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 64 years old?
Where in Lengyelország
- NZOZ „PRO-FEMINA” Piotr Piech i in Spólka JawnaBedzin, LengyelországNo longer taking part
- Copernicus Podmiot Leczniczy Sp. z o.oGdansk, LengyelországNo longer taking part
- NEURO-MEDIC Sp. z o. o.Katowice, LengyelországNo longer taking part
- Novo-Med Zielinski I Wspolnicy Sp. j.Katowice, LengyelországNo longer taking part
- Resmedica Sp. z o.o.Kielce, LengyelországNo longer taking part
- Centrum Neurologii Krzysztof SelmajŁódź, LengyelországNo longer taking part
- Neurologiczny NZOZPlewiska, LengyelországNo longer taking part
- Centrum Medyczne HCP Sp. z o.o.Poznan, LengyelországNo longer taking part
- Ilkowski I Partnerzy sp.p. LekarzyPoznan, LengyelországNo longer taking part
- Med Polonia Sp z o.o.Poznan, LengyelországNo longer taking part
- EUROMEDIS Sp z o oSzczecin, LengyelországNo longer taking part
- NeuroProtect Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, LengyelországNo longer taking part
- Clinhouse Sp. z o.o.Zabrze, LengyelországNo longer taking part
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrze, LengyelországNo longer taking part
- ProNeuro Centrum MedyczneZory, LengyelországNo longer taking part
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 Inc.
- Trial code
- EU 2022-501622-37-00
- Record updated
- 2026. november 2.
- Original description
1. PK Group: To demonstrate PK comparability of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus in patients with RRMSRead full original descriptionShow less
1. PK Group: To demonstrate PK comparability of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus in patients with RRMS
Inclusion: Patient is male or female aged between 18 years and 55 years (both inclusive); Patient diagnosed as Multiple Sclerosis (MS) in accordance with the revised McDonald criteria (2017); 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.