pediatric arthritis study of certolizumab pegol

Conditions: Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

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).

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)

Keywords: cimzia jia polyarticular oligoarticular enthesitis-related-arthritis juvenile idiopathic arthritis juvenile psoriatic arthritis certolizumab pegol pascal cdp870