Polyarticular-course Juvenile Idiopathic Arthritis (JIA)Phase 3PASCALNCT01550003
Pediatric Arthritis Study of Certolizumab Pegol
A Phase 3 study testing Certolizumab Pegol (CZP) in people with Polyarticular-course Juvenile Idiopathic Arthritis (JIA), run by UCB BIOSCIENCES GmbH at 36 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- Certolizumab Pegol (CZP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 8 Mar 2012to 8 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
United States20 sites
Ra0043 70
Avon, Ohio, 44011
Ra0043 74
Charlotte, North Carolina, 28203
Ra0043 82
Chicago, Illinois, 60611
Ra0043 90
Chicago, Illinois, 60637
Ra0043 73
Cincinnati, Ohio, 45229
Ra0043 78
Cleveland, Ohio, 44109
Ra0043 95
Cleveland, Ohio, 44195
Ra0043 86
Columbus, Ohio, 43205-2694
Ra0043 76
Durham, North Carolina, 27710
Ra0043 80
Hackensack, New Jersey, 07601
Ra0043 83
Hartford, Connecticut, 06106
Ra0043 75
Indianapolis, Indiana, 46202
Ra0043 71
Little Rock, Arkansas, 72202
Ra0043 77
Livingston, New Jersey, 07039
Ra0043 79
Los Angeles, California, 90027-6062
Ra0043 85
New Hyde Park, New York, 11042
Ra0043 87
New York, New York, 10032
Ra0043 89
Portland, Oregon, 97227
Ra0043 84
San Francisco, California, 94143
Ra0043 81
Washington D.C., District of Columbia, 20010
Mexico4 sites
Ra0043 31
México
Ra0043 32
Mexico City
Ra0043 30
Monterrey
Ra0043 33
San Luis Potosí City
Russia4 sites
Ra0043 41
Moscow
Ra0043 43
Moscow
Ra0043 40
Saint Petersburg
Ra0043 42
Tolyatti
About this study
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)
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).
Read the 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.
- Being tested
- Certolizumab Pegol (CZP)
- Keywords
- Cimzia, JIA, Polyarticular, Oligoarticular, Enthesitis-related-Arthritis, Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, Certolizumab Pegol, PASCAL, CDP870
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab Pegol (CZP)Drug
Also called Cimzia
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);
Certolizumab Pegol (CZP)Drug
Also called Cimzia
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.
Original CZP regimen (prior to implementation of protocol amendments 4 and 5 and after implementation of protocol amendment 9):
- 10 to < 20 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc); treatment dose = 50 mg Q2W (1 x 0.25 mL sc);
- 20 to < 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc,); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);
- ≥ 40 kg: Loading dose = 400 mg Q2W (2 x 1.0 mL sc); treatment dose = 200 mg Q2W (1 x 1.0 mL sc);
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab Pegol | Experimental | Active treatment with Certolizumab Pegol; dose adjustment is based on weight. Receives: Drug: Certolizumab Pegol (CZP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).
Measured: Week 16
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.
Measured: Week 48
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16
Number of participants with anti-CZP antibodies were reported.
Measured: Week 16
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
Number of participants with anti-CZP antibodies were reported.
Measured: Week 48
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.
Measured: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
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.
Measured: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Secondary outcomes (4)
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)
Measured: Week 16
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
Measured: Week 16
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
Measured: Week 16
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
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study start8 Mar 2012
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyarticular-course Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550003
- Sponsor's protocol ID
- RA0043
- Acronym
- PASCAL
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2012
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
- Expanded access
- Available
Publications
Brunner HI, Grebenkina L, Nikishina I, Alexeeva E, Chasnyk V, Abud-Mendoza C, Rubio-Perez N, Schmeling H, Del Rocio Maldonado-Velazquez M, Brown D, Zeft A, Morgan E, Rabinovich CE, Kingsbury D, Bukulmez H, Gottlieb B, Griffin T, Imundo L, Tarvin S, Silverman E, Shaughnessy L, Shimizu S, Williams P, Lledo-Garcia R, Utturkar G, Ufuktepe B, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO); the Pediatric Rheumatology Collaborative Study Group (PRCSG). Pharmacokinetics, Effectiveness and Safety of Certolizumab Pegol in Children and Adolescents With Active Juvenile Idiopathic Arthritis: 9+-Year Results From a Multicenter, Open-Label Study. Arthritis Rheumatol. 2026 Jul 13. doi: 10.1002/art.70274. Online ahead of print.
PubMed 42439289
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01550003
- Acronym / sponsor ID
- PASCAL / RA0043
- Keywords
- Cimzia, JIA, Polyarticular, Oligoarticular, Enthesitis-related-Arthritis, Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, Certolizumab Pegol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 8 Mar 2012 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certolizumab Pegol | Experimental | Drug: Certolizumab Pegol (CZP)Active treatment with Certolizumab Pegol; dose adjustment is based on weight. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab Pegol (CZP)Also: CimziaCZP 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); | Drug | Certolizumab Pegol |
| Certolizumab Pegol (CZP)Also: CimziaCZP 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. Original CZP regimen (prior to implementation of protocol amendments 4 and 5 and after implementation of protocol amendment 9): * 10 to < 20 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); * 20 to < 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc,); treatment dose = 100 mg Q2W (1 x 0.5 mL sc); * ≥ 40 kg: Loading dose = 400 mg Q2W (2 x 1.0 mL sc); treatment dose = 200 mg Q2W (1 x 1.0 mL sc); | Drug | Certolizumab Pegol |
Primary outcome
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
Time frame: Week 16
Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
Time frame: 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
Time frame: 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
Time frame: Week 48
Number of participants with anti-CZP antibodies were reported.
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study
Time frame: 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study
Time frame: 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.
4 secondary outcomes
Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
Time frame: Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
Time frame: Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16
Time frame: Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42439289Brunner HI, Grebenkina L, Nikishina I, Alexeeva E, Chasnyk V, Abud-Mendoza C, Rubio-Perez N, Schmeling H, Del Rocio Maldonado-Velazquez M, Brown D, Zeft A, Morgan E, Rabinovich CE, Kingsbury D, Bukulmez H, Gottlieb B, Griffin T, Imundo L, Tarvin S, Silverman E, Shaughnessy L, Shimizu S, Williams P, Lledo-Garcia R, Utturkar G, Ufuktepe B, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO); the Pediatric Rheumatology Collaborative Study Group (PRCSG). Pharmacokinetics, Effectiveness and Safety of Certolizumab Pegol in Children and Adolescents With Active Juvenile Idiopathic Arthritis: 9+-Year Results From a Multicenter, Open-Label Study. Arthritis Rheumatol. 2026 Jul 13. doi: 10.1002/art.70274. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab Pegol (CZP) in people with Polyarticular-course Juvenile Idiopathic Arthritis (JIA), run by UCB BIOSCIENCES GmbH at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Mexico, Russia, Brazil, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 (time frame: Week 16). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.