Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004381-24 | EudraCT Number |
Not provided
Not provided
higher than projected discontinuation rate during Maintenance Phase
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The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance High-Dose | Active Comparator | Maintenance High-Dose group: 400 mg Certolizumab Pegol for subjects ≥ 40 kg or 200 mg Certolizumab Pegol for subjects 20 to < 40 kg |
|
| Maintenance Low-Dose | Active Comparator | Maintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects ≥ 40 kg or 100 mg Certolizumab Pegol for subjects 20 to < 40 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Drug | 400 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg *prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects in Clinical Remission at Week 62 | Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | Week 62 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | Week 62 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
During an Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W). Subjects who showed a clinical response at Week 6 were randomized in a 1:1 ratio to one of 2 dose groups.
Subjects who did not respond at Week 6 were withdrawn from the study.
The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Induction Only | Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Period (Weeks 0 to 6) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Certolizumab Pegol | Drug | 200 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg *prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
|
|
| Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. A negative value in change from Baseline indicates an improvement from Baseline to Week 62. | From Week 0 to Week 62 |
| Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) | Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | From Week 0 to Week 62 |
| C-Reactive Protein (CRP) Levels at Week 62 | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD) | Week 62 |
| Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator. | From Week 0 to Week 62 |
| Erythrocyte Sedimentation Rate (ESR) at Week 62 | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). | Week 62 |
| Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator. | From Week 0 to Week 62 |
| Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development. | From Week 0 to Week 62 |
| Percentage of Subjects Who Initiated Steroid Tapering | Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose. | From Week 2 up to Week 8 |
| Percentage of Subjects in Corticosteroid-free Remission at the End of the Study | Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available. | Last/Withdrawal Visit (up to Week 62) |
| Los Angeles |
| California |
| United States |
| Orange | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Hartford | Connecticut | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Lexington | Kentucky | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Rochester | Minnesota | United States |
| Morristown | New Jersey | United States |
| New Hyde Park | New York | United States |
| Cincinnati | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Seattle | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Randwick | New South Wales | Australia |
| Herston | Queensland | Australia |
| Parkville | Victoria | Australia |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Halifax | Nova Scotia | Canada |
| Hamilton | Ontario | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Grafton | Auckland | New Zealand |
| Christchurch | Canterbury | New Zealand |
| FG001 | Maintenance Low-Dose | Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
| FG002 | Maintenance High-Dose | Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (Weeks 8 to 62) |
|
|
The Baseline characteristics refer to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction Only | Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
|
| BG001 | Maintenance Low-Dose | Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
| BG002 | Maintenance High-Dose | Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter |
| |||||||||||||||
| Body Surface Area (BSA) | Mean | Standard Deviation | square meter |
|
| 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 Subjects in Clinical Remission at Week 62 | Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | Full Analysis Set (FAS) population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 62 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores. | Posted | Mean | Standard Deviation | Score on a scale | Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. A negative value in change from Baseline indicates an improvement from Baseline to Week 62. | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores. | Posted | Mean | Standard Deviation | units on a scale | From Week 0 to Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) | Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. | Full Analysis Set (FAS) population | Posted | Number | 95% Confidence Interval | percentage of participants | From Week 0 to Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | C-Reactive Protein (CRP) Levels at Week 62 | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD) | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels. | Posted | Geometric Mean | 95% Confidence Interval | mg/L | Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator. | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From Week 0 to Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Erythrocyte Sedimentation Rate (ESR) at Week 62 | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR). | Posted | Geometric Mean | 95% Confidence Interval | mm/h | Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator. | Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR). | Posted | Geometric Mean | 95% Confidence Interval | ratio | From Week 0 to Week 62 |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development. | Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores. | Posted | Number | participants | From Week 0 to Week 62 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Initiated Steroid Tapering | Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose. | Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of subjects | From Week 2 up to Week 8 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in Corticosteroid-free Remission at the End of the Study | Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available. | Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period. | Posted | Number | 95% Confidence Interval | percentage of paticipants | Last/Withdrawal Visit (up to Week 62) |
|
Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
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 | Induction Period | Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
| 6 | 99 | 59 | 99 | ||
| EG001 | Maintenance Low-Dose | Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg | 4 | 37 | 28 | 37 | ||
| EG002 | Maintenance High-Dose | Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg *prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg | 4 | 35 | 27 | 35 | ||
| EG003 | Overall Study | Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62). | 14 | 99 | 78 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| 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 |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Protocol Violation |
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| Withdrawal by Subject |
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| Other reason |
|
| 12-17 years |
|
| Male |
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| Asian |
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| Black |
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| Native Hawaiian or other Pacific islander |
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| White |
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| Other / Mixed |
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