Crohn's Disease
Conditions
Keywords
Certolizumab Pegol, Cimzia®, Crohn's Disease, Children and Adolescents with Crohn's Disease
Brief summary
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.
Interventions
DRUGcertolizumab pegol
400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments when their participation in C87035 was terminated when the study was stopped by UBC * Subject completed all assessments required for Week 62/Visit 23 at the time of termination * Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD) throughout study
Exclusion criteria
* Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did not complete all of the Week 62 assessments when their participation from C87035 was terminated when the study was stopped by UCB but did not complete all assessments required for Week 62/Visit 23 at the time of termination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Discontinuing Treatment Due to a 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. |
| Number of Subjects Who Develop Anti-nuclear Antibodies During the Study | At the time of completion or termination visit (up to 298 weeks) | 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. |
| Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study | At the time of completion or termination visit (up to 298 weeks) | 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. |
| Percentage of Subjects in Clinical Remission | At the time of completion or termination visit (up to 298 weeks) | Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10) |
Countries
Australia, Canada, United States
Participant flow
Recruitment details
The study started to enroll patients in August 2010 and concluded in November 2017.
Pre-assignment details
The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 12 |
| Total Title | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative decision | 1 | 0 |
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | PI discretion | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Certolizumab Pegol: Low-dose Group (Weight Adjusted) | Certolizumab Pegol: High-dose Group (Weight Adjusted) | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 11 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 13.5 years STANDARD_DEVIATION 2.4 | 13.9 years STANDARD_DEVIATION 2.9 | 13.8 years STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Black | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 10 | 0 / 2 |
| other Total, other adverse events | 2 / 4 | 5 / 10 | 2 / 2 |
| serious Total, serious adverse events | 0 / 4 | 4 / 10 | 1 / 2 |
Outcome results
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.
Time frame: During study treatment (up to 303 weeks)
Population: The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | Subjects | 2 Participants |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | Subjects | 6 Participants |
| Certolizumab Pegol: Re-Induction Group - (SS) | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) | Subjects | 2 Participants |
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.
Time frame: During study treatment (up to 303 weeks)
Population: The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) | 2 Participants |
| Certolizumab Pegol: Re-Induction Group - (SS) | Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
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.
Time frame: At the time of completion or termination visit (up to 298 weeks)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | Number of Subjects Who Develop Anti-nuclear Antibodies During the Study | 0 Participants |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | Number of Subjects Who Develop Anti-nuclear Antibodies During the Study | 3 Participants |
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.
Time frame: At the time of completion or termination visit (up to 298 weeks)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study | Subjects | 0 Participants |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study | Subjects | 0 Participants |
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)
Time frame: At the time of completion or termination visit (up to 298 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS) | Percentage of Subjects in Clinical Remission | 100 Percentage of particpiants |
| Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS) | Percentage of Subjects in Clinical Remission | 44.4 Percentage of particpiants |