EU-approved RoActemra

DRUG3 trials

Sponsors

Fresenius Kabi SwissBioSim GmbH, Celltrion

Conditions

HealthyRheumatoid Arthritis

Phase 1

Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

CompletedNCT03282851

Fresenius Kabi SwissBioSim GmbHHealthy

Start: 2017-11-27End: 2019-10-01Updated: 2020-02-12

Phase 3

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

CompletedNCT04512001

Fresenius Kabi SwissBioSim GmbHRheumatoid Arthritis

Start: 2020-08-03End: 2022-06-06Updated: 2023-06-27

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

CompletedNCT05489224

CelltrionRheumatoid Arthritis

Start: 2022-09-14End: 2023-11-23Updated: 2024-10-08

Related Papers

Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis

Clinical Drug Investigation2025-07-121 citations

Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study

RMD Open2024-02-016 citations