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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003849-15 | EudraCT Number |
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This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 SC | Experimental |
| |
| Placebo SC | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 SC (Infliximab) | Biological | Subcutaneous injection of CT-P13 SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Clinical Remission at Week 54 | Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Patients Achieving Clinical Response at Week 54 | Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum Zdrowia MDM | Warsaw | 00-728 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41986154 | Derived | Colombel JF, Danese S, Schreiber S, Sands BE, Yarur AJ, Kang A, Kim DH, Lee YN, Hanauer SB. Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials. United European Gastroenterol J. 2026 Apr;14(3):e70205. doi: 10.1002/ueg2.70205. | |
| 41849243 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P13 IV 5mg/kg | Induction phase: Patients who enrolled received induction doses of CT-P13 5mg/kg via intravenous (IV) infusion at Weeks 0, 2, and 6. |
| FG001 | CT-P13 SC 120 mg | Maintenance phase: Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks. |
| FG002 | Placebo | Maintenance phase: Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Phase |
| |||||||||||||
| Maintenance Phase |
|
All-randomized population
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P13 SC 120 mg | CT-P13 SC 120 mg |
| BG001 | Placebo | Placebo |
| BG002 |
| 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 | Percentage of Patients Achieving Clinical Remission at Week 54 | Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | All-randomized population | Posted | Count of Participants | Participants | Week 54 |
|
For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported.
Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient.
For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
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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 | CT-P13 IV 5 mg/kg | Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia (Study drug unrelated) | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning | CELLTRION, Inc. | +82-32-850-4160 | YunJu.Bae@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 4, 2020 | Aug 9, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2022 | Jul 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Placebo SC |
| Other |
Subcutaneous injection of Placebo SC |
|
| Week 54 |
| Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 | Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved. | Week 54 |
| Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 | Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |
| Dubinsky MC, Schreiber S, Yarur AJ, Sands BE, Hanauer SB, Danese S, Yu H, Kim DH, Lee YN, Colombel JF. Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. Inflamm Bowel Dis. 2026 Mar 18:izag017. doi: 10.1093/ibd/izag017. Online ahead of print. |
| 40243842 | Derived | Colombel JF, Sandborn WJ, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Kim JM, Park G, Lee J, Lee J, Ryu JY, Sands BE, Hanauer SB. Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY). J Crohns Colitis. 2025 Jun 4;19(6):jjaf060. doi: 10.1093/ecco-jcc/jjaf060. |
| 38788861 | Derived | Hanauer SB, Sands BE, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Yang S, Lee J, Lee J, Kim JM, Park G, Sandborn WJ, Colombel JF. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY). Gastroenterology. 2024 Oct;167(5):919-933. doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23. |
| NOT COMPLETED |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage Patients Achieving Clinical Response at Week 54 | Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. | All-randomized population | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 | Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved. | All-randomized population | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 | Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Patients who used oral corticosteroids at baseline among the All-randomized population | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| 0 |
| 548 |
| 23 |
| 548 |
| 89 |
| 548 |
| EG001 | CT-P13 SC 120 mg | Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included. | 0 | 296 | 15 | 296 | 60 | 296 |
| EG002 | Placebo | Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included. | 0 | 140 | 4 | 140 | 37 | 140 |
| Iron deficiency anaemia (study drug unrelated) | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Aortic valve incompetence (study drug unrelated) | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cardiac failure (study drug unrelated) | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Colitis ulcerative (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Duodenal ulcer (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Duodenal ulcer perforation (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Intestinal obstruction (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Intestinal strangulation (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Large intestine perforation (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pancreatitis acute (study drug related) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rectal haemorrhage (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Appendicitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 pneumonia (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Cellulitis (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Cystitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Cytomegalovirus infection (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Peritonitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Salpingitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urosepsis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Anastomic leak (study drug unrelated) | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Clavicle fracture (study drug unrelated) | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Infusion related reaction (study drug related) | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Arthritis (study drug unrelated) | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Colorectal adenoma (study drug unrelated) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Neuromyopathy (study drug unrelated) | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Ureterolithiasis (study drug unrelated) | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cervical dysplasia (study drug unrelated) | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
|
| Deep vein thrombosis (study drug unrelated) | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |