NCT05489224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

July 24, 2022

Results QC Date

August 5, 2024

Last Update Submit

September 12, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24

    The DAS28(ESR) score was derived using the following formulae: DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln\[ESR\])+(0.014 ×GH) Where: * TJC28 = number of tender joints (0-28): tender joint count (TJC) * SJC28 = number of swollen joints (0-28): swollen joint count (SJC) * ESR = ESR measurement (mm/hour) * GH = patient's global disease activity measured on VAS (mm: 0-100) DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.

    Week 24

Secondary Outcomes (3)

  • Mean Change From Baseline in DAS28 (ESR) at Week 32

    Week 32

  • ACR20, ACR50, and ACR70 Response Rate at Week 24

    Week 24

  • ACR20, ACR50, and ACR70 Response Rate at Week 32

    Week 32

Study Arms (2)

CT-P47

EXPERIMENTAL

CT-P47(Tocilizumab)

Biological: CT-P47

EU-approved RoActemra

ACTIVE COMPARATOR

EU-approved RoActemra(Tocilizumab)

Biological: CT-P47Biological: EU-approved RoActemra

Interventions

CT-P47BIOLOGICAL

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

CT-P47EU-approved RoActemra
EU-approved RoActemraBIOLOGICAL

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

EU-approved RoActemra

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is male or female aged 18 to 75 years old, both inclusive.
  • 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.

You may not qualify if:

  • 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.
  • Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INTER CLINIC Piotr Adrian Klimiuk

Bialystok, Poland

Location

Related Publications (1)

  • Burmester G, Trefler J, Racewicz A, Jaworski J, Zielinska A, Krogulec M, Jeka S, Wojciechowski R, Kolossa K, Dudek A, Krajewska-Wlodarczyk M, Hrycaj P, Klimiuk PA, Kim S, Suh J, Yang G, Kim Y, Jung Y, Park G, Smolen JS. Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis. Clin Drug Investig. 2025 Aug;45(8):551-563. doi: 10.1007/s40261-025-01453-8. Epub 2025 Jul 12.

    PMID: 40650731DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Head of Clinical Planning Department 3
Organization
CELLTRION, Inc.
jeehye.suh@celltrion.com
+82-32-850-4167

Study Officials

  • Klimiuk Piotr

    INTER CLINIC Piotr Adrian Klimiuk

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

August 5, 2022

Study Start

September 14, 2022

Primary Completion

June 29, 2023

Study Completion

November 23, 2023

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)