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

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489224
• Other study ID #: CT-P47 3.1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Celltrion
• Contact: Yujin Hyoung
• Phone: 032-850-5000
• Email: yujin.hyoung[@]celltrion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 448
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• CT-P47
CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
• EU-approved RoActemra
EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline in Disease Activity Score 28 (DAS28) using Erythrocyte Sedimentation Rate (ESR)	DAS28 (ESR) is assessed using the following variables: tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR), and patients assessment of global disease activity	Week 12
Secondary	Proportion of Patients Achieving an American College of Rheumatology (ACR)20 response	ACR20 responders are patients with at least 20% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR	Week 52
Secondary	Proportion of Patients Achieving an ACR50 response	ACR50 responders are patients with at least 50% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR	Week 52
Secondary	Proportion of Patients Achieving an ACR70 response	ACR70 responders are patients with at least 70% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR	Week 52