A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Interventions
- Registration Number
- NCT03725007
- Lead Sponsor
- AbbVie
- Brief Summary
This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 124
- Participant have total body weight of 10 kg or higher at the time of screening.
- Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: <=4 joints within first 6 months of disease and >4 joints thereafter).
- Participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (LOM) plus pain on motion and/or tenderness with palpitation, with LOM present in at least three of the active joints.
- If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of <=20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
- If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1.
- Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
- Participant have prior exposure to JAK inhibitor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Participants of age group 12 to <18 years receiving dose B Upadacitinib Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol. Participants of age group 12 to <18 years receiving dose A Upadacitinib Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol. Participants of age group 6 to <12 years receiving dose A Upadacitinib Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol. Participants of age group 2 to <18 years receiving dose A Upadacitinib Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol. Participants of age group 2 to <6 years receiving dose A Upadacitinib Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
- Primary Outcome Measures
Name Time Method Part 1: Time to maximum observed plasma concentration (Tmax) Day 7 Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
Part 1: Maximum observed plasma concentration (Cmax) Day 7 Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Part 1: Apparent oral clearance at steady state (CL/F) Day 7 Clearance is defined as the volume of plasma cleared of the drug per unit time.
Treatment Emergent Adverse Events (TEAEs) Up to approximately 156 weeks Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau) Day 7 The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.
Part 1: Half-life Day 7 Half life of updadacitinib will be determined using non-compartmental method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Duplicate_McGill University Health Centre /ID# 251252
🇨🇦Montreal, Quebec, Canada
Ospedale Pediatrico Bambino Gesù /ID# 203835
🇮🇹Rome, Roma, Italy
St Marianna University School Of Medicine /ID# 246478
🇯🇵Kawasaki-shi, Kanagawa, Japan
Institute of Science Tokyo Hospital /ID# 246500
🇯🇵Bunkyo-ku, Tokyo, Japan
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
🇺🇸Chicago, Illinois, United States
Duplicate_University of Louisville /ID# 202896
🇺🇸Louisville, Kentucky, United States
Boston Children's Hospital /ID# 202993
🇺🇸Boston, Massachusetts, United States
Cincinnati Childrens Hospital Medical Center /ID# 209697
🇺🇸Cincinnati, Ohio, United States
Randall Children's Hospital /ID# 213609
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia /ID# 209617
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (25 remaining)Duplicate_McGill University Health Centre /ID# 251252🇨🇦Montreal, Quebec, Canada