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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004497-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 - CT-P13 | Experimental | CT-P13 followed by CT-P13 from Week 30 |
|
| CT-P13 - Remicade | Active Comparator | CT-P13 followed by Remicade from Week 30 |
|
| Remicade - Remicade | Active Comparator | Remicade followed by Remicade from Week 30 |
|
| Remicade - CT-P13 | Experimental | Remicade followed by CT-P13 from Week 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 | Biological | CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value. | at Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. | Week 30 |
| The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35435862 | Derived | Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15. | |
| 34216825 | Derived | Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P13 - CT-P13 | CT-P13 followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| FG001 | CT-P13 - Remicade | CT-P13 followed by Remicade from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| FG002 | Remicade - Remicade | Remicade followed by Remicade from Week 30 Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| FG003 | Remicade - CT-P13 | Remicade followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P13 - CT-P13 | CT-P13 followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| BG001 | CT-P13 - Remicade |
| 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 | The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value. | CT-P13 treatment group including CT-P13 - CT-P13 and CT-P13 - Remicade treatment groups. Remicade treatment group including Remicade - Remicade and Remicade - CT-P13 treatment groups. | Posted | Count of Participants | Participants | at Week 6 |
|
Up to End-of-Study
End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
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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 - CT-P13 | CT-P13 followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BoYoung Choi / Clinical Operation Team Leader | Celltrion, Inc. | +82-32-850-6594 | BoYoung.Choi@celltrion.com |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000591237 | CT-P13 |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Remicade | Biological | Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
|
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. |
| Week 54 |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 6 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | Week 6 |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 30 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | Week 30 |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | Week 54 |
| The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. | Up to Week 30 |
| The Short Inflammatory Bowel Disease Questionnaire | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. | Baseline and Week 54 |
| 33245751 | Derived | Wong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242. |
| 30929895 | Derived | Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28. |
| 29411318 | Derived | Husereau D, Feagan B, Selya-Hammer C. Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching. Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0. |
CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
| BG002 | Remicade - Remicade | Remicade followed by Remicade from Week 30 Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| BG003 | Remicade - CT-P13 | Remicade followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
|
|
| Secondary | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. | CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group | Posted | Count of Participants | Participants | Week 30 |
|
|
|
| Secondary | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | The Number and Percentage of Patients Achieving Clinical Remission at Week 6 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Secondary | The Number and Percentage of Patients Achieving Clinical Remission at Week 30 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group | Posted | Count of Participants | Participants | Week 30 |
|
|
|
| Secondary | The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | Clinical remission was defined as an absolute CDAI score of less than 150 points. | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. | Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit. CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group | Posted | Mean | Standard Deviation | scores on a scale | Up to Week 30 |
|
|
|
| Secondary | The Short Inflammatory Bowel Disease Questionnaire | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. | Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 54 |
|
|
|
| 0 |
| 56 |
| 4 |
| 56 |
| 37 |
| 56 |
| EG001 | CT-P13 - Remicade | CT-P13 followed by Remicade from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 0 | 55 | 4 | 55 | 36 | 55 |
| EG002 | Remicade - Remicade | Remicade followed by Remicade from Week 30 Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 0 | 54 | 4 | 54 | 36 | 54 |
| EG003 | Remicade - CT-P13 | Remicade followed by CT-P13 from Week 30 CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 0 | 55 | 7 | 55 | 40 | 55 |
| Anal fissure | Gastrointestinal disorders | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | Systematic Assessment |
|
| Anal abscess | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Peritoneal tuberculosis | Infections and infestations | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Generalised oedema | General disorders | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infusion-related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
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| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Week 6 |
|
|
| Week 30 |
|
|
|
| Week 54 |
|
|