Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Active Rheumatoid Arthritis Clinical Trial

Official title: A Randomized Controlled, Double-blind, Phase III, Multicenter Clinical Study of HS628 Versus Actemra® in Combination With Methotrexate as Therapy in Patients With Moderate to Severe Rheumatoid Arthritis

Status Completed

Clinical Trial Summary

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in combination with MTX, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current MTX therapy. The study comprises a 24-week treatment phase, followed by a 4-week safety observation period.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

• NCT number: NCT06048224
• Study type: Interventional
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: December 28, 2020
• Completion date: January 31, 2022