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Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX — ALVOFLEX  

Rheumatoid Arthritis Clinical Trial

Official title:
Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects With Moderate to Severe Rheumatoid Arthritis

Clinical Trial Summary

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05842213
Study type Interventional
Source Alvotech Swiss AG
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 30, 2023
Completion date August 2024
View Details
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