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Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis

NCT06475508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2024-07-03

No results posted yet for this study

Summary

This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.

Conditions

Interventions

BIOLOGICAL

Complarate®

The investigational drug Complarate® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.

BIOLOGICAL

Actemra®

The reference drug Actemra® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · JSC GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-01-05
Completion
2024-06-11

Countries

  • Russia

Study Locations

More Related Trials

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 NCT06475508 on ClinicalTrials.gov