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Pediatric Arthritis Study of Certolizumab Pegol (PASCAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01550003
Recruitment Status : Active, not recruiting
First Posted : March 9, 2012
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information
First Submitted Date  ICMJE March 7, 2012
First Posted Date  ICMJE March 9, 2012
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE March 2012
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 16 [ Time Frame: Week 16 ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 48 [ Time Frame: Week 48 ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 248 [ Time Frame: Week 248 ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 16 weeks [ Time Frame: Within the first 16 weeks ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within the first 48 weeks [ Time Frame: Within the first 48 weeks ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result within 248 weeks [ Time Frame: Within 248 weeks ]
  • Percentage of Subjects with at least one Adverse Event (AE) within the first 16 weeks [ Time Frame: Within the first 16 weeks ]
  • Percentage of Subjects with at least one Adverse Event (AE) within the first 56 weeks [ Time Frame: Within the first 56 weeks ]
  • Percentage of Subjects with at least one Adverse Event (AE) within 248 weeks [ Time Frame: Within 248 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 16 [ Time Frame: Week 16 ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 48 [ Time Frame: Week 48 ]
  • Certolizumab Pegol (CZP) Plasma Concentration (µg/mL) at Week 186 [ Time Frame: Week 186 ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  • Percentage of Subjects with Positive anti-Certolizumab Pegol (anti-CZP) Antibody Result from Baseline to Week 186 [ Time Frame: Baseline to Week 186 ]
  • Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 56 [ Time Frame: Baseline to Week 56 ]
  • Percentage of Subjects with at least one Adverse Event (AE) from Baseline to Week 186 [ Time Frame: Baseline to Week 186 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of Subjects meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 [ Time Frame: Baseline to Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Arthritis Study of Certolizumab Pegol
Official Title  ICMJE 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)
Brief 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Certolizumab Pegol
Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
Intervention: Drug: Certolizumab Pegol (CZP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 29, 2015)
163
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2012)
125
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Chile,   Mexico,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550003
Other Study ID Numbers  ICMJE RA0043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES GmbH )
Study Sponsor  ICMJE UCB BIOSCIENCES GmbH
Collaborators  ICMJE PRA Health Sciences
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date March 2020

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