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A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

NCT05489224 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2024-10-08

Study results available
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Summary

This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

CT-P47

CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)

BIOLOGICAL

EU-approved RoActemra

EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W

Sponsors & Collaborators

Principal Investigators

  • Klimiuk Piotr · INTER CLINIC Piotr Adrian Klimiuk

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
2022-09-14
Primary Completion
2023-06-29
Completion
2023-11-23
FDA Drug
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05489224 on ClinicalTrials.gov