NCT01550003CompletedPhase 3
Pediatric Arthritis Study of Certolizumab Pegol
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 193 (actual)
- First submitted
- 7 Mar 2012
- Start date
- 8 Mar 2012
- Primary completion date
- 8 Apr 2024
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Diseases
- Psoriatic arthritis
- NCT number
- NCT01550003
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 193
- From 8 Mar 2012 to the primary completion date, 8 Apr 2024
- 36 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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)
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.