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Pediatric Arthritis Study of Certolizumab Pegol
Sponsor: UCB BIOSCIENCES GmbH
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).
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)
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
193
Start Date
2012-03-08
Completion Date
2024-04-08
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
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);
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);
Locations (36)
Ra0043 71
Little Rock, Arkansas, United States
Ra0043 79
Los Angeles, California, United States
Ra0043 84
San Francisco, California, United States
Ra0043 83
Hartford, Connecticut, United States
Ra0043 81
Washington D.C., District of Columbia, United States
Ra0043 82
Chicago, Illinois, United States
Ra0043 90
Chicago, Illinois, United States
Ra0043 75
Indianapolis, Indiana, United States
Ra0043 80
Hackensack, New Jersey, United States
Ra0043 77
Livingston, New Jersey, United States
Ra0043 85
New Hyde Park, New York, United States
Ra0043 87
New York, New York, United States
Ra0043 74
Charlotte, North Carolina, United States
Ra0043 76
Durham, North Carolina, United States
Ra0043 70
Avon, Ohio, United States
Ra0043 73
Cincinnati, Ohio, United States
Ra0043 78
Cleveland, Ohio, United States
Ra0043 95
Cleveland, Ohio, United States
Ra0043 86
Columbus, Ohio, United States
Ra0043 89
Portland, Oregon, United States
RA0043 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