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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

NCT06048224 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2023-09-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-28
Primary Completion
2021-09-14
Completion
2022-01-31

Countries

  • China

Study Locations

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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 NCT06048224 on ClinicalTrials.gov