About this trial
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
Eligibility criteria
Qualifiers
Participant with a body mass index (BMI) within the 5th to 95th percentiles for the age and gender (based on World Health Organization BMI charts). Participant must have a minimum weight of 15 kg.
Participant must meet the International League of Associations for Rheumatology classification for 1 of the following categories and have, according to the investigator's judgment, moderately to severely active disease that is not adequately controlled with his/her current therapy.
Rheumatoid factor (RF)-positive polyarthritis
RF-negative polyarthritis
Disqualifiers
Participant with persistent oligoarthritis.
Participant with undifferentiated arthritis.
Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).
Active infection that is clinically significant, as per judgment of the investigator.
Trial design
Treatments tested in this trial
- Filgotinib
- Filgotinib