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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-11-23

Brief Summary

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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.

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Detailed Description

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CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P47

CT-P47(Tocilizumab)

Group Type EXPERIMENTAL

CT-P47

Intervention Type BIOLOGICAL

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

EU-approved RoActemra

EU-approved RoActemra(Tocilizumab)

Group Type ACTIVE_COMPARATOR

CT-P47

Intervention Type BIOLOGICAL

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

EU-approved RoActemra

Intervention Type BIOLOGICAL

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

Interventions

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CT-P47

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

Intervention Type BIOLOGICAL

EU-approved RoActemra

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Patient is male or female aged 18 to 75 years old, both inclusive.
2. Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.

Exclusion Criteria

1. Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
2. Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
3. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No