NCT04512001

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Fresenius Kabi SwissBioSim GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MSB11456	Participants will receive MSB11456 subcutaneously, once a week.
DRUG	EU-approved RoActemra	Participants will receive EU-approved RoActemra® subcutaneously, once a week.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-08-31
• Completion: 2022-06-06
• First posted: 2020-08-13
• Last updated: 2023-06-27
• Results posted: 2022-10-24

Locations

85 sites across 9 countries: Bulgaria, Czechia, Georgia, Hungary, Moldova, Poland, Russia, Serbia, Slovakia

Regulatory

• FDA-regulated drug study