A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
ClinicalTrials.gov processed this data on April 29, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified April 2024 by UCB BIOSCIENCES GmbH, PRA Health Sciences
Sponsor
UCB BIOSCIENCES GmbHInformation Provided by (Responsible Party)
UCB BIOSCIENCES GmbHClinicaltrials.gov Identifier
NCT01550003Other Study ID Numbers: RA0043
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: April 30, 2024
Last Verified: April 2024
History of Changes
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Study Description
The overall study consists of a Screening Period of up to 4 weeks and an Open-Label Treatment Period which will continue until the approval of the marketing application for the Polyarticular-course Juvenile Idiopathic Arthritis (JIA) indication in the study participant's country or region or until further notice from UCB (approximately 4-6 years duration; depending on region). A Final Visit will be conducted 12 weeks after last dose of study medication. Overall, study visits will occur monthly during the first 6 months and every 2 months afterwards. All patients will receive active treatment with Certolizumab Pegol. The dose will depend on actual weight. Home dosing will be allowed between study visits.If less than 50 % of the study population achieves an adequate response to the treatment (American College of Rheumatology Pediatric 30 % (PedACR30) response) at Week 16, the study will be entirely discontinued.
Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 193 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA) |
Study Start Date | March 8, 2012 |
Actual Primary Completion Date | April 8, 2024 |
Actual Study Completion Date | April 8, 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Certolizumab Pegol (CZP) Plasma Concentration level at Week 16 [Week 16] Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
- Certolizumab Pegol (CZP) Plasma Concentration level at Week 48 [Week 48] Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
- Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 16 [Week 16]
- Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 48 [Week 48]
- Incidence of serious treatment-emergent adverse events (TEAEs) during the study [From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)] A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above - Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the Investigational Medicinal Product (IMP) during the study [From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)] An Adverse Event (AE) is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Secondary Outcome Measures
- American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16 [Week 16] The assessment of the PedACR30 at Week 16 compared to Baseline is based on a 30 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %.
The 6 core set measures are:
Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both)
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (VAS)
CHAQ completed by parent or caregiver
Parent's Global Assessment of Overall Well-Being (VAS)
Acute phase reactant (CRP) - American College of Rheumatology Pediatric 50 % (PedACR50) Response at Week 16 [Week 16] The assessment of the PedACR50 at Week 16 compared to Baseline is based on a 50 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %.
The 6 core set measures are:
Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both)
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (VAS)
CHAQ completed by parent or caregiver
Parent's Global Assessment of Overall Well-Being (VAS)
Acute phase reactant (CRP) - American College of Rheumatology Pediatric 70 % (PedACR70) Response at Week 16 [Week 16] The assessment of the PedACR70 at Week 16 compared to Baseline is based on a 70 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %.
The 6 core set measures are:
Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both)
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (VAS)
CHAQ completed by parent or caregiver
Parent's Global Assessment of Overall Well-Being (VAS)
Acute phase reactant (CRP) - American College of Rheumatology Pediatric 90 % (PedACR90) Response at Week 16 [Week 16] The assessment of the PedACR90 at Week 16 compared to Baseline is based on a 90 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %.
The 6 core set measures are:
Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both)
Number of joints with limitation of range of motion
Physician's Global Assessment of Disease Activity (VAS)
CHAQ completed by parent or caregiver
Parent's Global Assessment of Overall Well-Being (VAS)
Acute phase reactant (CRP)
Eligibility Criteria
Ages Eligible for Study | 2 Years to 17 Years (Child) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | UCB BIOSCIENCES GmbH, PRA Health Sciences |
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PRA Health Sciences | |
Locations |
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Investigators |
More Information
Additional Relevant MeSH Terms
- Arthritis
- Arthritis, Juvenile
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases