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The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab pegol: high-dose group | Experimental | 400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
|
| Certolizumab pegol: low-dose group (weight adjusted) | Experimental | 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| certolizumab pegol | Drug | 400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | During study treatment (up to 303 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | During study treatment (up to 303 weeks) |
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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 |
|---|---|---|---|---|---|---|
| 114 | Orange | California | United States | |||
| 111 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.
The study started to enroll patients in August 2010 and concluded in November 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol: Low-dose Group (Weight Adjusted) | 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 8, 2012 | Nov 27, 2018 |
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|
| certolizumab pegol | Drug | 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg |
|
|
| Number of Subjects Who Develop Anti-nuclear Antibodies During the Study |
Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits. |
| At the time of completion or termination visit (up to 298 weeks) |
| Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study | Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits. | At the time of completion or termination visit (up to 298 weeks) |
| Percentage of Subjects in Clinical Remission | Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10) | At the time of completion or termination visit (up to 298 weeks) |
| Aurora |
| Colorado |
| United States |
| 103 | Atlanta | Georgia | United States |
| 116 | Atlanta | Georgia | United States |
| 112 | Shreveport | Louisiana | United States |
| 104 | Baltimore | Maryland | United States |
| 126 | Morristown | New Jersey | United States |
| 301 | Parkville | Victoria | Australia |
| 203 | Edmonton | Alberta | Canada |
| 204 | Hamilton | Ontario | Canada |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) |
400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. |
| Re-Induction |
|
| COMPLETED | 6 |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set which included all subjects enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol: Low-dose Group (Weight Adjusted) | 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. |
| BG001 | Certolizumab Pegol: High-dose Group (Weight Adjusted) | 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. |
| BG002 | Total Title |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. | Posted | Count of Participants | Participants | During study treatment (up to 303 weeks) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. | Posted | Count of Participants | Participants | During study treatment (up to 303 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Develop Anti-nuclear Antibodies During the Study | Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits. | The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study. | Posted | Count of Participants | Participants | At the time of completion or termination visit (up to 298 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study | Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits. | The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study. | Posted | Count of Participants | Participants | At the time of completion or termination visit (up to 298 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in Clinical Remission | Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10) | The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of study treatment in this study and who had at least 1 efficacy measurement after the first injection of this study. | Posted | Number | Percentage of particpiants | At the time of completion or termination visit (up to 298 weeks) |
|
During study treatment (up to 303 weeks)
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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 | Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | 200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG001 | Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. | 0 | 10 | 4 | 10 | 5 | 10 |
| EG002 | Certolizumab Pegol: Re-Induction Group - (SS) | If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study. | 0 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Pancreatitis viral | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA20.1 | Non-systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA20.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA20.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA20.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA20.1 | Non-systematic Assessment |
| |
| Ultrasound abdomen | Investigations | MedDRA20.1 | Non-systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA20.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA20.1 | Non-systematic Assessment |
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| Enuresis | Psychiatric disorders | MedDRA20.1 | Non-systematic Assessment |
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| Dysmenorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Asthma exercise induced | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA20.1 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA20.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2018 | Nov 27, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 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 |
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| >=65 years |
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| Male |
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| White |
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