Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Conditions
Keywords
Cimzia, JIA, Polyarticular, Oligoarticular, Enthesitis-related-Arthritis, Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, Certolizumab Pegol, PASCAL, CDP870
Brief summary
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).
Detailed 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.
Interventions
CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution. Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range. Reduced CZP regimen (after implementation of protocol amendments 4 and 5): * 10 to \< 20 kg: Loading dose = 50 mg Q2W (1 x 0.25 mL sc); treatment dose = 50 mg Q4W (1 x 0.25 mL sc); * 20 to \< 40 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc,); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); * ≥ 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);
Sponsors
PRA Health Sciences
UCB BIOSCIENCES GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2) * Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2) * Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA) * Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline * Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment) * If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m\^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response * If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose
Exclusion criteria
* Study participant has previously been exposed to more than 2 biologic agents * Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug * Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer * Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction * Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not) * Study participant has a history of systemic JIA, with or without systemic features * Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication * Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related) * Study participant has active uveitis or a history of active uveitis within the preceding 6 months * Study participant has current, chronic or recurrent clinically significant infections * Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening \[Visit 1\]), had a recent (within the 6 months prior to Screening \[Visit 1\]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 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 (70 days after final dose of CZP) (maximum up to 12 years) | An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure. |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Week 48 | Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL. |
| Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | Week 16 | Number of participants with anti-CZP antibodies were reported. |
| Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | Week 48 | Number of participants with anti-CZP antibodies were reported. |
| Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and 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. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Week 16 | Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | Week 16 | PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
| Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | Week 16 | PedACR70- at least 70% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
| Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | Week 16 | PedACR90- at least 90% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
| Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | Week 16 | PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * C-reactive protein (CRP) |
Countries
Argentina, Brazil, Canada, Chile, Mexico, Russia, United States
Participant flow
Recruitment details
The study started to enroll participants in March 2012 and concluded in April 2024.
Pre-assignment details
Participant Flow refers to the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| Any CZP Dose - Weight Group: 10 - <20 kg Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study. | 18 |
| Any CZP Dose - Weight Group: 20 - <40 kg Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study. | 63 |
| Any CZP Dose - Weight Group: >=40 kg Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study. | 112 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 9 | 15 |
| Overall Study | By medical decision and approved by the sponsor | 0 | 0 | 1 |
| Overall Study | Consent withdrawn | 2 | 11 | 23 |
| Overall Study | Discontinuation | 0 | 1 | 0 |
| Overall Study | Early discontinuation at request of sponsor | 0 | 2 | 4 |
| Overall Study | Lack of Efficacy | 4 | 11 | 15 |
| Overall Study | Lost to Follow-up | 1 | 4 | 8 |
| Overall Study | Missing | 1 | 0 | 2 |
| Overall Study | Non-compliance | 0 | 0 | 1 |
| Overall Study | Patient not compliance | 0 | 0 | 1 |
| Overall Study | Patient reached adulthood | 0 | 1 | 0 |
| Overall Study | Patient transition to adult care | 0 | 0 | 1 |
| Overall Study | Per Sponsor request | 1 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Noncompliance | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 2 |
| Overall Study | Site closure | 0 | 2 | 0 |
| Overall Study | Sponsor's decision | 1 | 5 | 4 |
| Overall Study | Sponsor's order | 0 | 3 | 3 |
| Overall Study | Study closed | 0 | 1 | 0 |
| Overall Study | Study closure | 0 | 1 | 1 |
| Overall Study | Study closure as announced by sponsor | 7 | 6 | 24 |
| Overall Study | Subject is in college/unable to come to visits | 0 | 0 | 1 |
| Overall Study | Subject mother passed away | 0 | 1 | 0 |
| Overall Study | Subject moved to rheumatology and out of study | 0 | 1 | 1 |
| Overall Study | Subject was able to obtain commercial cimzia | 0 | 0 | 1 |
| Overall Study | Switching to adult rheumatologist | 0 | 0 | 1 |
| Overall Study | Transitioned to adult rheumatology | 0 | 0 | 1 |
| Overall Study | Treatment or 12 week follow up visit completed | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Any CZP Dose - Weight Group: 10 - <20 kg | Any CZP Dose - Weight Group: 20 - <40 kg | Any CZP Dose - Weight Group: >=40 kg | Total |
|---|---|---|---|---|
| Age, Continuous | 5.4 years STANDARD_DEVIATION 1.3 | 9.1 years STANDARD_DEVIATION 2 | 14.5 years STANDARD_DEVIATION 2.2 | 11.9 years STANDARD_DEVIATION 3.8 |
| Age, Customized 12 - <18 years | 0 Participants | 8 Participants | 99 Participants | 107 Participants |
| Age, Customized 24 months - <12 years | 18 Participants | 55 Participants | 13 Participants | 86 Participants |
| Race/Ethnicity, Customized American Indian/ Alaska Native | 0 Participants | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 18 Participants | 27 Participants | 55 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 8 Participants | 45 Participants | 85 Participants | 138 Participants |
| Race/Ethnicity, Customized Other/Mixed | 1 Participants | 7 Participants | 14 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 53 Participants | 85 Participants | 155 Participants |
| Sex: Female, Male Female | 11 Participants | 43 Participants | 76 Participants | 130 Participants |
| Sex: Female, Male Male | 7 Participants | 20 Participants | 36 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 63 | 3 / 112 |
| other Total, other adverse events | 16 / 18 | 59 / 63 | 98 / 112 |
| serious Total, serious adverse events | 5 / 18 | 20 / 63 | 21 / 112 |
Outcome results
Primary
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).
Time frame: Week 16
Population: The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 1.6166 ug/ml |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 9.2277 ug/ml |
| Reduced CZP Dose - Weight Group: >=40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 13.8928 ug/ml |
| Original CZP Dose - Weight Group: 10 - <20 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 22.9060 ug/ml |
| Original CZP Dose - Weight Group: 20 - <40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 25.7752 ug/ml |
| Original CZP Dose - Weight Group: >=40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | 33.5680 ug/ml |
Primary
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.
Time frame: Week 48
Population: The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | 4.7404 ug/ml |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | 8.4459 ug/ml |
| Reduced CZP Dose - Weight Group: >=40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | 12.2987 ug/ml |
| Original CZP Dose - Weight Group: 10 - <20 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | NA ug/ml |
| Original CZP Dose - Weight Group: 20 - <40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | 20.7048 ug/ml |
| Original CZP Dose - Weight Group: >=40 kg | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | 25.5940 ug/ml |
Primary
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16
Number of participants with anti-CZP antibodies were reported.
Time frame: Week 16
Population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | 69 Participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | 77 Participants |
Primary
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
Number of participants with anti-CZP antibodies were reported.
Time frame: Week 48
Population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | 58 Participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | 47 Participants |
Primary
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and 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. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.
Time frame: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | 5 Participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | 20 Participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | 21 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study
An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure.
Time frame: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study | 0 Participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study | 9 Participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study | 16 Participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * C-reactive protein (CRP)
Time frame: Week 16
Population: Full analysis set (FAS): all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | 83.3 percentage of participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | 77.8 percentage of participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | 79.5 percentage of participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP
Time frame: Week 16
Population: FAS:all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, PGA of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | 66.7 percentage of participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | 71.4 percentage of participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | 74.1 percentage of participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16
PedACR70- at least 70% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP
Time frame: Week 16
Population: FAS consisted of all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | 44.4 percentage of participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | 57.1 percentage of participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | 54.5 percentage of participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16
PedACR90- at least 90% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP
Time frame: Week 16
Population: FAS consisted of all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced CZP Dose -Weight Group: 10 - <20 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | 22.2 percentage of participants |
| Reduced CZP Dose - Weight Group: 20 - <40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | 25.4 percentage of participants |
| Reduced CZP Dose - Weight Group: >=40 kg | Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | 29.5 percentage of participants |