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MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

NCT04512001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2023-06-27

Study results available
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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

Interventions

DRUG

MSB11456

Participants will receive MSB11456 subcutaneously, once a week.

DRUG

EU-approved RoActemra

Participants will receive EU-approved RoActemra® subcutaneously, once a week.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-08-31
Completion
2022-06-06
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Georgia
  • Hungary
  • Moldova
  • Poland
  • Russia
  • Serbia
  • Slovakia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512001 on ClinicalTrials.gov