Clinical trial NCT01550003: Pediatric Arthritis Study of Certolizumab Pegol
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2012-03-09
Enrollment: 193
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16
timeFrame: Week 16
measure: Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
timeFrame: Week 48
measure: Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16
timeFrame: Week 16
measure: Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
timeFrame: Week 48
measure: Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study
timeFrame: From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Secondary outcomes:
measure: Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
timeFrame: Week 16
measure: Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
timeFrame: Week 16
measure: Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16
timeFrame: Week 16
measure: Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Ra0043 71
state: Arkansas
city: Los Angeles
country: United States
facility: Ra0043 79
state: California
city: San Francisco
country: United States
facility: Ra0043 84
state: California
city: Hartford
country: United States
facility: Ra0043 83
state: Connecticut
city: Washington
country: United States
facility: Ra0043 81
state: District of Columbia
city: Chicago
country: United States
facility: Ra0043 82
state: Illinois
city: Chicago
country: United States
facility: Ra0043 90
state: Illinois
city: Indianapolis
country: United States
facility: Ra0043 75
state: Indiana
city: Hackensack
country: United States
facility: Ra0043 80
state: New Jersey
city: Livingston
country: United States
facility: Ra0043 77
state: New Jersey
city: New Hyde Park
country: United States
facility: Ra0043 85
state: New York
city: New York
country: United States
facility: Ra0043 87
state: New York
city: Charlotte
country: United States
facility: Ra0043 74
state: North Carolina
city: Durham
country: United States
facility: Ra0043 76
state: North Carolina
city: Avon
country: United States
facility: Ra0043 70
state: Ohio
city: Cincinnati
country: United States
facility: Ra0043 73
state: Ohio
city: Cleveland
country: United States
facility: Ra0043 78
state: Ohio
city: Cleveland
country: United States
facility: Ra0043 95
state: Ohio
city: Columbus
country: United States
facility: Ra0043 86
state: Ohio
city: Portland
country: United States
facility: Ra0043 89
state: Oregon
city: Buenos Aires
country: Argentina
facility: RA0043 2
city: Curitiba
country: Brazil
facility: Ra0043 15
city: Porto Alegre
country: Brazil
facility: Ra0043 14
city: Sao Paulo
country: Brazil
facility: Ra0043 12
city: Calgary
country: Canada
facility: Ra0043 21
city: Montreal
country: Canada
facility: Ra0043 22
city: Toronto
country: Canada
facility: Ra0043 20
city: Santiago
country: Chile
facility: Ra0043 60
city: Mexico D.F.
country: Mexico
facility: Ra0043 32
city: Mexico
country: Mexico
facility: Ra0043 31
city: Monterrey
country: Mexico
facility: Ra0043 30
city: San Luis Potosi
country: Mexico
facility: Ra0043 33
city: Moscow
country: Russian Federation
facility: Ra0043 41
city: Moscow
country: Russian Federation
facility: Ra0043 43
city: St. Petersburg
country: Russian Federation
facility: Ra0043 40
city: Tolyatti
country: Russian Federation
facility: Ra0043 42
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: