Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001087-30 | EudraCT Number |
Not provided
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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 Crohn's Disease
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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 (Based on CDAI) at Week 54 | Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |
| Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level. | Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving CDAI-100 Response at Week 54 | Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biopharma Informatic - Houston | Houston | Texas | 77084 | United States | ||
| Vitebsk Regional Clinical Hospital |
| 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. | |
| 41910935 |
Not provided
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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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Phase |
|
Not provided
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 | Aug 3, 2020 | Aug 9, 2023 |
Not provided
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| Placebo SC |
| Other |
Subcutaneous injection of Placebo SC |
|
| Week 54 |
| Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |
| Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |
| Vitebsk |
| Belarus |
| Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia | Bulgaria |
| Clinical Hospital Centre Osijek | Osijek | Croatia |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France |
| Praxis Prof. Herbert Kellner | München | Germany |
| University General Hospital of Heraklion | Heraklion | Greece |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary |
| Nirmal Hospital | Surat | India |
| Sheba Medical Center | Ramat Gan | Israel |
| Fondazione Policlinico Universitario A Gemelli-Rome | Roma | Italy |
| Tsujinaka Hospital | Kashiwa | Japan |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| BRCR Global Mexico | Guadalajara | Mexico |
| IMSP Institute of Clinical Cardiology | Chisinau | Moldova |
| Hospital Nacional Cayetano Heredia | San MartÃn de Porres | Peru |
| Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia | Bydgoszcz | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland |
| Dr.Carol Davila Emergency University Central Military Hospital | Bucharest | Romania |
| Klinika YZI 4D | Pyatigorsk | Russia |
| BioTekhServis | Saint Petersburg | Russia |
| Clinical Hospital Centar Zvezdara | Belgrade | Serbia |
| Fakultna nemocnica s poliklinikou F. D. Roosevelta | Banská Bystrica | Slovakia |
| CLINRESCO, ARWYP Medical Suites | Johannesburg | South Africa |
| Hospital Arquitecto Marcide | Ferrol | Spain |
| Ege University Medical Faculty | Izmir | Turkey (Türkiye) |
| Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkassy | Ukraine |
| Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council | Zaporizhzhia | Ukraine |
| Schreiber S, Sands BE, Danese S, Loftus EV Jr, Jeong AL, Kim DH, Lee YN, Colombel JF. Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn's Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial. Adv Ther. 2026 Jun;43(6):2510-2526. doi: 10.1007/s12325-026-03533-3. Epub 2026 Mar 30. |
| 41849243 | Derived | 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. |
Maintenance phase: Patients who were classified as CDAI-100 responder at Week 10 received CT-P13 120 mg 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 240 mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
| FG002 | Placebo | Maintenance phase: Patients who were classified as CDAI-100 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 240 mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Maintenance Phase |
|
All-randomized population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT-P13 SC 120 mg | CT-P13 SC 120 mg |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. 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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level. | All-randomized population | Posted | Count of Participants | Participants | Week 54 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving CDAI-100 Response at Week 54 | Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. 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 Clinical Remission (Based on AP and SF) at Week 54 | Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. 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.
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 | CT-P13 IV 5 mg/kg | Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6. | 0 | 396 | 12 | 396 | 51 | 396 |
| EG001 | CT-P13 SC 120 mg (Including 240 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. | 1 | 238 | 16 | 238 | 75 | 238 |
| EG002 | CT-P13 SC 120 mg | Patients who administered CT-P13 SC 120 mg 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. | 1 | 238 | 15 | 238 | 70 | 238 |
| EG003 | CT-P13 SC 120 mg to 240 mg | Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22. | 0 | 45 | 1 | 45 | 9 | 45 |
| EG004 | 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 | 105 | 8 | 105 | 30 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia (study drug unrelated) | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency (study drug unrelated) | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Crohn's disease (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemorrhoids (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal perforation (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Subileus (study drug unrelated) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Accidental death (study drug unrelated) | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal abscess (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal sepsis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal wall abscess (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abscess intestinal (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Anal abscess (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthritis bacterial (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bartholinitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchiolitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal tuberculosis (study drug related) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Orchitis (study drug unrelated) | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Peritonitis (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 |
| |
| Humerus 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 |
| |
| Skin laceration (study drug unrelated) | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased (study drug related) | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration (study drug unrelated) | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colon cancer stage III (study drug unrelated) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Altered state of consciousness (study drug unrelated) | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neurovascular conflict (study drug unrelated) | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder (study drug unrelated) | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Psychotic disorder (study drug unrelated) | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory failure (study drug unrelated) | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism (study drug unrelated) | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acne fulminans (study drug unrelated) | Skin and subcutaneous tissue 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 |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning | CELLTRION, Inc. | +82-32-850-4160 | YunJu.Bae@celltrion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2022 | Aug 9, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| Bulgaria |
|
| Croatia |
|
| Czechia |
|
| France |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| India |
|
| Israel |
|
| Italy |
|
| Japan |
|
| Latvia |
|
| Mexico |
|
| Moldova |
|
| Peru |
|
| Poland |
|
| Romania |
|
| Russia |
|
| Serbia |
|
| Slovakia |
|
| South Africa |
|
| Spain |
|
| Turkey |
|
| Ukraine |
|
| United States |
|
|
|
|
|
|