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Pædiatrisk arthritis undersøgelse af Certolizumab Pegol (PASCAL)

1. september 2026 opdateret af: UCB BIOSCIENCES GmbH

En multicenter, åben-label undersøgelse for at vurdere farmakokinetikken, sikkerheden og effektiviteten af ​​Certolizumab Pegol hos børn og unge med moderat til svært aktiv polyartikulært forløb juvenil idiopatisk 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

193

Fase

  • Fase 3

Udvidet adgang

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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • RA0043 2
  • Brasilien
      • Curitiba, Brasilien
        • Ra0043 15
      • Porto Alegre, Brasilien
        • Ra0043 14
      • São Paulo, Brasilien
        • Ra0043 12
  • Canada
      • Calgary, Canada
        • Ra0043 21
      • Montreal, Canada
        • Ra0043 22
      • Toronto, Canada
        • Ra0043 20
  • Chile
      • Santiago, Chile
        • Ra0043 60
  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72202
        • Ra0043 71
    • California
      • Los Angeles, California, Forenede Stater, 90027-6062
        • Ra0043 79
      • San Francisco, California, Forenede Stater, 94143
        • Ra0043 84
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Ra0043 83
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Ra0043 81
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Ra0043 82
      • Chicago, Illinois, Forenede Stater, 60637
        • Ra0043 90
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Ra0043 75
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Ra0043 80
      • Livingston, New Jersey, Forenede Stater, 07039
        • Ra0043 77
    • New York
      • New Hyde Park, New York, Forenede Stater, 11042
        • Ra0043 85
      • New York, New York, Forenede Stater, 10032
        • Ra0043 87
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Ra0043 74
      • Durham, North Carolina, Forenede Stater, 27710
        • Ra0043 76
    • Ohio
      • Avon, Ohio, Forenede Stater, 44011
        • Ra0043 70
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Ra0043 73
      • Cleveland, Ohio, Forenede Stater, 44109
        • Ra0043 78
      • Cleveland, Ohio, Forenede Stater, 44195
        • Ra0043 95
      • Columbus, Ohio, Forenede Stater, 43205-2694
        • Ra0043 86
    • Oregon
      • Portland, Oregon, Forenede Stater, 97227
        • Ra0043 89
  • Mexico
      • Mexico City, Mexico
        • Ra0043 32
      • Monterrey, Mexico
        • Ra0043 30
      • México, Mexico
        • Ra0043 31
      • San Luis Potosí City, Mexico
        • Ra0043 33
  • Rusland
      • Moscow, Rusland
        • Ra0043 41
      • Moscow, Rusland
        • Ra0043 43
      • Saint Petersburg, Rusland
        • Ra0043 40
      • Tolyatti, Rusland
        • Ra0043 42

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Certolizumab Pegol

Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
Medicin: 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);
Andre navne:
  • Cimzia
Medicin: 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.

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);
Andre navne:
  • Cimzia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
Tidsramme: Week 16

Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).
Week 16
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
Tidsramme: Week 48

Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.
Week 48
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16
Tidsramme: Week 16

Number of participants with anti-CZP antibodies were reported.
Week 16
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
Tidsramme: Week 48

Number of participants with anti-CZP antibodies were reported.
Week 48
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study
Tidsramme: 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.
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
Tidsramme: 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.
From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
Tidsramme: 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)
Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
Tidsramme: 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
Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16
Tidsramme: 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
Week 16
Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16
Tidsramme: 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
Week 16

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UCB BIOSCIENCES GmbH

Samarbejdspartnere

PRA Health Sciences

Efterforskere

  • Studieleder: UCB Cares, 001 844 599 2273 (UCB)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. marts 2012

Primær færdiggørelse (Faktiske)

8. april 2024

Studieafslutning (Faktiske)

8. april 2024

Datoer for studieregistrering

Først indsendt

7. marts 2012

Først indsendt, der opfyldte QC-kriterier

7. marts 2012

Først opslået (Anslået)

9. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RA0043

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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