Rheumatoid ArthritisPhase 3NCT05489224

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

A Phase 3 study testing CT-P47 and EU-approved RoActemra in people with Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: CT-P47 and EU-approved RoActemra
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 471 participants
Where: 1 sitePoland
Study dates: 14 Sep 2022to 23 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

INTER CLINIC Piotr Adrian Klimiuk
Bialystok

Other trials in Poland

About this study

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

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.

Read the 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.

Conditions: Rheumatoid Arthritis
Being tested: CT-P47, EU-approved RoActemra
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P47Biological
CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
EU-approved RoActemraBiological
EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W

Study groups in NCT05489224
Study group	Role	What they receive
CT-P47	Experimental	CT-P47(Tocilizumab) Receives: Biological: CT-P47
EU-approved RoActemra	Active comparator	EU-approved RoActemra(Tocilizumab) Receives: Biological: CT-P47; Biological: EU-approved RoActemra

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 24

Secondary outcomes (3)

Mean Change From Baseline in DAS28 (ESR) at Week 32
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.
Measured: Week 32
ACR20, ACR50, and ACR70 Response Rate at Week 24
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Measured: Week 24
ACR20, ACR50, and ACR70 Response Rate at Week 32
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Measured: Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202223 Nov 2023

First posted5 Aug 2022
Study start14 Sep 2022
Primary completion29 Jun 2023
Study completion23 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05489224
Sponsor's protocol ID: CT-P47 3.1
Status last verified: Sep 2024
First submitted: 24 Jul 2022
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40650731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05489224
Acronym / sponsor ID: CT-P47 3.1
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 471 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 14 Sep 2022 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 23 Nov 2023 (actual)
First posted: 5 Aug 2022 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT-P47	Experimental	Biological: CT-P47CT-P47(Tocilizumab)
EU-approved RoActemra	Active comparator	Biological: CT-P47, Biological: EU-approved RoActemraEU-approved RoActemra(Tocilizumab)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P47CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)	Biological	CT-P47, EU-approved RoActemra
EU-approved RoActemraEU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W	Biological	EU-approved RoActemra

Primary outcome

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

3 secondary outcomes

Mean Change From Baseline in DAS28 (ESR) at Week 32
Time frame: Week 32
ACR20, ACR50, and ACR70 Response Rate at Week 24
Time frame: Week 24
ACR20, ACR50, and ACR70 Response Rate at Week 32
Time frame: Week 32

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P47/CT-P47 Maintenance	234	225
RoActemra/RoActemra Maintenance	237	219
Switched to CT-P47	0	0

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

Time frame: Week 24. Least squares mean (Standard Error). Unit: units on a scale

Measure	CT-P47 n = 234	RoActemra n = 237
Value	-3.77 (0.120)	-3.67 (0.118)

CT-P47 vs RoActemra: Treatment difference and 90% CI: -0.10 (90% CI -0.30 to 0.10), ANCOVA

Population analysed: ITT set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]). For Treatment Period II in this page, results up to Week 32 cut-off of the first CSR were included.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Period I: CT-P47	10 of 234 (4.3%)	140 of 234 (59.8%)	0 of 234
Treatment Period I: RoActemra	9 of 237 (3.8%)	143 of 237 (60.3%)	0 of 237
Treatment Period II: CT-P47 Maintenance	4 of 225 (1.8%)	54 of 225 (24%)	1 of 225
Treatment Period II: RoActemra Maintenance	3 of 109 (2.8%)	26 of 109 (23.9%)	0 of 109
Treatment Period II: Switched to CT-P47	2 of 110 (1.8%)	23 of 110 (20.9%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40650731Burmester 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.
Individual participant dataSharing planned: No

Related trials for Rheumatoid Arthritis

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Not yet recruitingPhase 1
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Not yet recruitingPhase 1
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Klimiuk Piotr principal investigator

INTER CLINIC Piotr Adrian Klimiuk

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P47 and EU-approved RoActemra in people with Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.