Pediatric Arthritis Study of Certolizumab Pegol

NCT01550003 | Completed Phase 3 Results DMC

• 1 other identifier: RA0043
• Study Type: interventional
• Target: 193
• Locations: 7 countries
• Sites: 36

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).

Conditions

Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Keywords

Cimzia; JIA; Polyarticular; Oligoarticular; Enthesitis-related-Arthritis; Juvenile Idiopathic Arthritis; Juvenile Psoriatic Arthritis; Certolizumab Pegol; PASCAL; CDP870

Outcome Measures

Primary Outcomes (6)

• Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16

  Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).

  Week 16

• Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48

  Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.

  Week 48

• Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16

  Number of participants with anti-CZP antibodies were reported.

  Week 16

• Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48

  Number of participants with anti-CZP antibodies were reported.

  Week 48

• Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study

  A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.

  From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study

  An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure.

  From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

Secondary Outcomes (4)

• Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16

  Week 16

• Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16

  Week 16

• Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16

  Week 16

• Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16

  Week 16

Study Arms (1)

Certolizumab Pegol

EXPERIMENTAL

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

Drug: Certolizumab Pegol (CZP)

Interventions

Certolizumab Pegol (CZP) 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);

Also known as: Cimzia

Certolizumab Pegol

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead
• PRA Health Sciences: collaborator

Study Sites (36)

Ra0043 71

Little Rock, Arkansas, 72202, United States

Location

Ra0043 79

Los Angeles, California, 90027-6062, United States

Location

Ra0043 84

San Francisco, California, 94143, United States

Location

Ra0043 83

Hartford, Connecticut, 06106, United States

Location

Ra0043 81

Washington D.C., District of Columbia, 20010, United States

Location

Ra0043 82

Chicago, Illinois, 60611, United States

Location

Ra0043 90

Chicago, Illinois, 60637, United States

Location

Ra0043 75

Indianapolis, Indiana, 46202, United States

Location

Ra0043 80

Hackensack, New Jersey, 07601, United States

Location

Ra0043 77

Livingston, New Jersey, 07039, United States

Location

Ra0043 85

New Hyde Park, New York, 11042, United States

Location

Ra0043 87

New York, New York, 10032, United States

Location

Ra0043 74

Charlotte, North Carolina, 28203, United States

Location

Ra0043 76

Durham, North Carolina, 27710, United States

Location

Ra0043 70

Avon, Ohio, 44011, United States

Location

Ra0043 73

Cincinnati, Ohio, 45229, United States

Location

Ra0043 78

Cleveland, Ohio, 44109, United States

Location

Ra0043 95

Cleveland, Ohio, 44195, United States

Location

Ra0043 86

Columbus, Ohio, 43205-2694, United States

Location

Ra0043 89

Portland, Oregon, 97227, United States

Location

RA0043 2

Buenos Aires, Argentina

Location

Ra0043 15

Curitiba, Brazil

Location

Ra0043 14

Porto Alegre, Brazil

Location

Ra0043 12

São Paulo, Brazil

Location

Ra0043 21

Calgary, Canada

Location

Ra0043 22

Montreal, Canada

Location

Ra0043 20

Toronto, Canada

Location

Ra0043 60

Santiago, Chile

Location

Ra0043 32

Mexico City, Mexico

Location

Ra0043 31

México, Mexico

Location

Ra0043 30

Monterrey, Mexico

Location

Ra0043 33

San Luis Potosí City, Mexico

Location

Ra0043 41

Moscow, Russia

Location

Ra0043 43

Moscow, Russia

Location

Ra0043 40

Saint Petersburg, Russia

Location

Ra0043 42

Tolyatti, Russia

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: March 8, 2012
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

US (20); ME (4); RU (4); CL (1); BR (3); CA (3); AR (1)