Pediatric Arthritis Study of Certolizumab Pegol (PASCAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by UCB Pharma
Sponsor:
Collaborator:
Pharm Research Associates Ltd. UK
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01550003
First received: March 7, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Drug: Certolizumab Pegol (CZP)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 248 [ Time Frame: Week 248 ] [ Designated as safety issue: No ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 16 weeks [ Time Frame: Within the first 16 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 48 weeks [ Time Frame: Within the first 48 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within 248 weeks [ Time Frame: Within 248 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects with at least one Adverse Event (AE) within the first 16 weeks [ Time Frame: Within the first 16 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects with at least one Adverse Event (AE) within the first 56 weeks [ Time Frame: Within the first 56 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects with at least one Adverse Event (AE) within 248 weeks [ Time Frame: Within 248 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: March 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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:

  • 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);
Other Name: Cimzia

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 subject'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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (Active Polyarticular-course JIA disease is defined as ≥ 5 joints with active Arthritis including: Polyarticular Rheumatoid Factor (RF)-positive, Polyarticular RF-negative, extended oligoarticular, Juvenile Psoriatic Arthritis and enthesitis-related Arthritis)
  • Children and adolescents, aged 2 to 17 years (inclusive); weight ≥ 10 kg
  • Inadequate response or intolerance to at least 1 Disease-Modifying Antirheumatic Drug (DMARD) (previous exposure to a maximum of 2 biologic agents will be allowed)
  • Methotrexate (MTX) and oral Corticosteroids will be allowed at stable doses prior to Screening
  • If not using Methotrexate (MTX), inadequate response or intolerance to MTX

Exclusion Criteria:

  • History of systemic JIA, with or without systemic features
  • Active Uveitis or a history of active Uveitis within the preceding 6 months
  • Known history of Tuberculosis (TB), or high risk of acquiring TB and latent TB infection; chronic, recurrent infection current sign or symptom which may indicate infection, or at high risk of infection
  • Viral Hepatitis or Human Immunodeficiency Virus (HIV) infection; live vaccination, including attenuated, within defined period prior to study entry or during the study (non-live vaccinations are permitted at any time prior to and during the study)
  • The use of, or dose changes to, specific medications (eg, non-biologic DMARDs, biologic DMARDs, oral and intramuscular/intravenous/intra-articular Corticosteroids) will not be allowed for defined periods of time prior to study entry
  • Previous exposure to Certolizumab Pegol (CZP), to more than 2 biologic DMARDs and previous lack of response to more than 1 Tumor Necrosis Factor (TNFα) antagonist drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550003

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 39 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Pharm Research Associates Ltd. UK
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01550003     History of Changes
Other Study ID Numbers: RA0043
Study First Received: March 7, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Protection Against Health Risks
Russia: Ministry of Health of the Russian Federation

Keywords provided by UCB Pharma:
Cimzia
JIA
Polyarticular
Oligoarticular
Enthesitis-related-Arthritis
Juvenile Idiopathic Arthritis
Juvenile Psoriatic Arthritis
Certolizumab Pegol
PASCAL
CDP870

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014