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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05489224
Recruitment Status : Not yet recruiting
First Posted : August 5, 2022
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: CT-P47 Biological: EU-approved RoActemra Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CT-P47
CT-P47(Tocilizumab)
 Biological: CT-P47
CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
Active Comparator: EU-approved RoActemra
EU-approved RoActemra(Tocilizumab)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in Disease Activity Score 28 (DAS28) using Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Week 12 ]
    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


Secondary Outcome Measures :
  1. Proportion of Patients Achieving an American College of Rheumatology (ACR)20 response [ Time Frame: Week 52 ]
    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

  2. Proportion of Patients Achieving an ACR50 response [ Time Frame: Week 52 ]
    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

  3. Proportion of Patients Achieving an ACR70 response [ Time Frame: Week 52 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489224


Contacts
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Contact: Yujin Hyoung 032-850-5000 yujin.hyoung@celltrion.com

Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: Klimiuk Piotr INTER CLINIC Piotr Adrian Klimiuk
More Information
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT05489224    
Other Study ID Numbers: CT-P47 3.1
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases