Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P47 | Experimental | CT-P47(Tocilizumab) |
|
| EU-approved RoActemra | Active Comparator | EU-approved RoActemra(Tocilizumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P47 | Biological | CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klimiuk Piotr | INTER CLINIC Piotr Adrian Klimiuk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INTER CLINIC Piotr Adrian Klimiuk | Bialystok | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40650731 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CT-P47/CT-P47 Maintenance | Treatment Period I: Patients who were initially randomly assigned to CT-P47 in Treatment Period I (from Week 0 to Week 20). Treatment Period II: All patients who received CT-P47 in Treatment Period I and continued to receive CT-P47 in Treatment Period II (from Week 24 to Week 48). |
| FG001 | RoActemra/RoActemra Maintenance | Treatment Period I: Patients who were initially randomly assigned to RoActemra in Treatment Period I (from Week 0 to Week 20). Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to continue RoActemra in Treatment Period II (from Week 24 to Week 48). |
| FG002 | Switched to CT-P47 | Treatment Period I: Not applicable Treatment Period II: Patients who received RoActemra in Treatment Period I and re-randomized to receive CT-P47 in Treatment Period II (from Week 24 to Week 48). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I |
|
| |||||||||||||||||||||
| Treatment Period II up to Week 32 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT-P47 | Patients who were initially randomly assigned to CT-P47 in Treatment Period I. |
| BG001 | RoActemra | Patients who were initially randomly assigned to RoActemra in Treatment Period I. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity. | ITT set | Posted | Least Squares Mean | Standard Error | units on a scale | Week 24 |
|
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.
Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. TEAEs with an actual/imputed start date prior to the 1st dosing in Treatment Period II, or TEAEs for those patients who did not administer study drug during Treatment Period II were included.
Treatment Period II: From the 1st dosing in Treatment Period II to Week 32. TEAEs with an actual/imputed start date on or after the date of 1st dosing in Treatment Period II were included.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Period I: CT-P47 | Patients who were initially randomly assigned to CT-P47 in Treatment Period I |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning Department 3 | CELLTRION, Inc. | +82-32-850-4167 | jeehye.suh@celltrion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Aug 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2024 | Aug 5, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EU-approved RoActemra | Biological | EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W |
|
| 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. | 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. | Week 32 |
| Lost to Follow-up |
|
| Physician Decision |
|
This data summary is based on the Week 32 results, so all patients were considered as Not Completed (whole study period; Week 52). All patients were considered as ongoing at the time of Week 32 data cut-off.
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Weight on Day 1 | Count of Participants | Participants |
|
| DAS28 (ESR) score at Screening | 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:
DAS28 (ESR) >5.1 was condisered to be a higher disease activity than DAS28 (ESR) ≤5.1. | Count of Participants | Participants |
|
| Prior biologic use approved for RA treatment | Count of Participants | Participants |
|
| RoActemra |
Patients who were initially randomly assigned to RoActemra in Treatment Period I. |
|
|
|
| Secondary | 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:
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity. | ITT-Treatment Period II Subset | Posted | Mean | Standard Deviation | units on a scale | Week 32 |
|
|
|
| Secondary | 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. | ITT set | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | 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. | ITT-Treatment Period II Subset | Posted | Count of Participants | Participants | Week 32 |
|
|
|
| 0 |
| 234 |
| 10 |
| 234 |
| 140 |
| 234 |
| EG001 | Treatment Period I: RoActemra | Patients who were initially randomly assigned to RoActemra in Treatment Period I | 0 | 237 | 9 | 237 | 143 | 237 |
| EG002 | Treatment Period II: CT-P47 Maintenance | Patients who received CT-P47 during Treatment Period I and continued to receive CT-P47 in Treatment Period II | 1 | 225 | 4 | 225 | 54 | 225 |
| EG003 | Treatment Period II: RoActemra Maintenance | Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to continue to receive RoActemra in Treatment Period II | 0 | 109 | 3 | 109 | 26 | 109 |
| EG004 | Treatment Period II: Switched to CT-P47 | Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II | 0 | 110 | 2 | 110 | 23 | 110 |
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
|
| Erysipelas | Infections and infestations | Systematic Assessment |
|
| Lyme disease | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Systematic Assessment |
|
| Urosepsis | Infections and infestations | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | Systematic Assessment |
|
| Peritonitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bone loss | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
|
| Interferon gamma release assay positive | Investigations | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Cervical cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Latent tuberculosis | Infections and infestations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Transaminases increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ACR70 |
|
| Title | Measurements |
|---|---|
|
| ACR70 |
|