Pediatric Arthritis Study of Certolizumab Pegol

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified August 2024 by UCB BIOSCIENCES GmbH
Sponsor
UCB BIOSCIENCES GmbH
Information Provided by (Responsible Party)
UCB BIOSCIENCES GmbH
Clinicaltrials.gov Identifier
NCT01550003
Other Study ID Numbers:
RA0043
First Submitted
March 6, 2012
First Posted
March 8, 2012
Results First Posted
September 25, 2024
Last Update Posted
October 22, 2024
Last Verified
August 2024

ClinicalTrials.gov processed this data on September 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Drug: Certolizumab Pegol (CZP)

Study Design

Study TypeInterventional
Actual Enrollment193 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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 DateMarch 7, 2012
Actual Primary Completion DateApril 7, 2024
Actual Study Completion DateApril 7, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Certolizumab Pegol
Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
Drug: Certolizumab Pegol (CZP)
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);

Outcome Measures

Primary Outcome Measures
  1. Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
    Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).
  2. Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
    Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.
  3. Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16
    Number of participants with anti-CZP antibodies were reported.
  4. Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
    Number of participants with anti-CZP antibodies were reported.
  5. 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.
  6. 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.
Secondary Outcome Measures
  1. 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)
  2. 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
  3. 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
  4. 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

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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)

Contacts and Locations

Sponsors and CollaboratorsUCB BIOSCIENCES GmbH
Locations
Ra0043 71 | Little Rock Arkansas, United States, 72202Ra0043 79 | Los Angeles California, United States, 90027-6062Ra0043 84 | San Francisco California, United States, 94143Ra0043 83 | Hartford Connecticut, United States, 06106Ra0043 81 | Washington D.C. District of Columbia, United States, 20010Ra0043 82 | Chicago Illinois, United States, 60611Ra0043 90 | Chicago Illinois, United States, 60637Ra0043 75 | Indianapolis Indiana, United States, 46202Ra0043 80 | Hackensack New Jersey, United States, 07601Ra0043 77 | Livingston New Jersey, United States, 07039Ra0043 85 | New Hyde Park New York, United States, 11042Ra0043 87 | New York New York, United States, 10032Ra0043 74 | Charlotte North Carolina, United States, 28203Ra0043 76 | Durham North Carolina, United States, 27710Ra0043 70 | Avon Ohio, United States, 44011Ra0043 73 | Cincinnati Ohio, United States, 45229Ra0043 78 | Cleveland Ohio, United States, 44109Ra0043 95 | Cleveland Ohio, United States, 44195Ra0043 86 | Columbus Ohio, United States, 43205-2694Ra0043 89 | Portland Oregon, United States, 97227RA0043 2 | Buenos Aires , Argentina, Ra0043 15 | Curitiba , Brazil, Ra0043 14 | Porto Alegre , Brazil, Ra0043 12 | São Paulo , Brazil, Ra0043 21 | Calgary , Canada, Ra0043 22 | Montreal , Canada, Ra0043 20 | Toronto , Canada, Ra0043 60 | Santiago , Chile, Ra0043 32 | Mexico City , Mexico, Ra0043 31 | México , Mexico, Ra0043 30 | Monterrey , Mexico, Ra0043 33 | San Luis Potosí City , Mexico, Ra0043 41 | Moscow , Russia, Ra0043 43 | Moscow , Russia, Ra0043 40 | Saint Petersburg , Russia, Ra0043 42 | Tolyatti , Russia,
Investigators
Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full Text)
Documents provided by UCB BIOSCIENCES GmbH: Study Protocol  April 26, 2020Documents provided by UCB BIOSCIENCES GmbH: Statistical Analysis Plan  May 22, 2024