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

Last updated: September 12, 2024
Sponsor: Celltrion
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Arthritis And Arthritic Pain

Treatment

CT-P47

EU-approved RoActemra

Clinical Study ID

NCT05489224
CT-P47 3.1
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 classificationcriteria for at least 24 weeks prior to the first administration of the study drug.

Exclusion

Exclusion Criteria:

  1. Patient who has previously received investigational or licensed product; targetedsynthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/oran interleukin-6 (IL-6) inhibitor for any purposes.

  2. Patient who has previously received more than 1 biologic agents approved for thetreatment of RA.

  3. Patient who has allergies to any of the excipients of study drug or any other murineand human proteins, or patient with a hypersensitivity to immunoglobulin products.

Study Design

Total Participants: 471
Treatment Group(s): 2
Primary Treatment: CT-P47
Phase: 3
Study Start date:
September 14, 2022
Estimated Completion Date:
November 23, 2023

Study 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.

Connect with a study center

  • INTER CLINIC Piotr Adrian Klimiuk

    Bialystok,
    Poland

    Site Not Available

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