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COMPLETED
NCT01550003
PHASE3

Pediatric Arthritis Study of Certolizumab Pegol

Sponsor: UCB BIOSCIENCES GmbH

View on ClinicalTrials.gov

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

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. 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);

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. 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