Pediatric Arthritis Study of Certolizumab Pegol

NCT ID: NCT01550003

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-08
• Study Completion Date: 2024-04-08

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 study participant'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.

Conditions

Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Certolizumab Pegol

Active treatment with Certolizumab Pegol; dose adjustment is based on weight.

Group Type: EXPERIMENTAL

Certolizumab Pegol (CZP)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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);

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);

Intervention Type: 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);

Intervention Type: DRUG

Other Intervention Names

Cimzia; Cimzia

Eligibility Criteria

Inclusion Criteria

• Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2)
• Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2)
• Study participants must have had 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 (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA)
• Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline
• Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment)
• If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response
• If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose

Exclusion Criteria

• Study participant has previously been exposed to more than 2 biologic agents
• Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
• Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
• Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
• Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
• Study participant has a history of systemic JIA, with or without systemic features
• Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
• Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
• Study participant has active uveitis or a history of active uveitis within the preceding 6 months
• Study participant has current, chronic or recurrent clinically significant infections
• Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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

Countries

United States; Argentina; Brazil; Canada; Chile; Mexico; Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RA0043

Identifier Type: -

Identifier Source: org_study_id