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Pediatric Arthritis Study of Certolizumab Pegol (PASCAL)

This study is currently recruiting participants.
Verified May 2013 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01550003
First received: March 7, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes

March 7, 2012
May 21, 2013
March 2012
January 2014   (final data collection date for primary outcome measure)
  • 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 186 [ Time Frame: Week 186 ] [ 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 186 weeks [ Time Frame: Within 186 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 186 weeks [ Time Frame: Within 186 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01550003 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pediatric Arthritis Study of Certolizumab Pegol
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 Phase 3, multicenter, open-label study to assess the pharmacokinetics (PK), safety, and efficacy of Certolizumab Pegol (CZP) in children and adolescents with moderately to severely active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).

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 3-5 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.
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis (JIA)
Drug: Certolizumab Pegol (CZP)

CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) 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 = 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);
Other Name: Cimzia
Experimental: Certolizumab Pegol
Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
Intervention: Drug: Certolizumab Pegol (CZP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
December 2016
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Polyarticular-course Juvenile Idiopathic Arthritis (JIA) 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
Both
2 Years to 17 Years
No
Contact: UCB Clinical Trial Call Center +1 877 822 9493
United States,   Argentina,   Canada,   Chile,   Mexico,   Russian Federation
 
NCT01550003
RA0043
No
UCB, Inc. ( UCB BIOSCIENCES GmbH )
UCB BIOSCIENCES GmbH
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP