NCT06048224

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 669 (actual)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	HS628+MTX	Participants will receive HS628 SC injections Q4W along with MTX orally for 24-week
DRUG	Actemra +MTX	Participants will receive tocilizumab SC injections Q4W along with MTX orally for 24-week

Timeline

• Start date: 2020-12-28
• Primary completion: 2021-09-14
• Completion: 2022-01-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China