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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001690-25 | EudraCT Number |
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This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P17 Subcutaneous(SC) (adalimumab) | Experimental | CT-P17 SC (adalimumab) |
|
| Humira SC (adalimumab) | Active Comparator | Humira SC (adalimumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P17 SC | Biological | Subcutaneous injection of Adalimumab 40mg every two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology(ACR)20 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) | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 and ACR70 Response Rate at Week 24 | 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 up to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinJi Ma | Celltrion, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Multiprofile Transport Hospital Tsar Boris III | Sofia | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34142111 | Derived | Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460. | |
| 33546755 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P17 Subcutaneous(SC) (Adalimumab) | Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24. Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48. |
| FG001 | EU-approved Humira SC (Adalimumab) | Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24. Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. |
| FG002 | Switched to CT-P17 | Treatment Period 1: N/A Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I (Week 0 to Week 26) |
|
| |||||||||||||||||||||
| Treatment Period II (Week 26 to Week 52) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P17 | Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. |
| BG001 | EU-approved Humira | Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | American College of Rheumatology(ACR)20 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) | Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | 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).
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment 1: CT-P17 | Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc. | 032-850-5806 | jiwoong.lim@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Aug 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2020 | Aug 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Humira SC | Biological | Subcutaneous injection of Adalimumab 40mg every two weeks |
|
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.
| Up to Week 52 |
| Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) | The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity. | Week 24 |
| Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) | The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity. | Up to Week 52 |
| Derived |
| Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7. |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Significant dose delay |
|
| Patient decision |
|
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | EU-approved Humira SC (Adalimumab) | Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24. Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. |
|
|
| Secondary | ACR50 and ACR70 Response Rate at Week 24 | ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20. | Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | ACR20, ACR50, and ACR70 Response Rate up to Week 52 | 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. | Intent-to-Treat (ITT) population. | Posted | Count of Participants | Participants | Up to Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) | The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity. | Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | Units on a scale | Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) | The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity. | Intent-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | Units on a scale | Up to Week 52 |
|
|
|
| 0 |
| 324 |
| 12 |
| 324 |
| 96 |
| 324 |
| EG001 | Treatment 1: EU-approved Humira | Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. | 0 | 324 | 19 | 324 | 118 | 324 |
| EG002 | Treatment 2: CT-P17 Maintenance | All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48. | 0 | 303 | 6 | 303 | 50 | 303 |
| EG003 | Treatment 2: Humira Maintenance | Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. | 0 | 152 | 3 | 152 | 35 | 152 |
| EG004 | Treatment 2: Switched to CT-P17 | Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. | 0 | 152 | 5 | 152 | 33 | 152 |
| Angina Unstable | Cardiac disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Retinal vein thrombosis | Eye disorders | Systematic Assessment |
|
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Nonalcoholic fatty liver disease | Hepatobiliary disorders | Systematic Assessment |
|
| Breast abscess | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Chronic tonsillitis | Infections and infestations | Systematic Assessment |
|
| Epididymitis | Infections and infestations | Systematic Assessment |
|
| Erysipelas | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Extradural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Benign muscle neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
|
| Rheumatoid lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | Systematic Assessment |
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| Polypectomy | Surgical and medical procedures | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Latent tuberculosis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| ACR70 at Week 52 |
|