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
- 122
- 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)
Cincinnati Childrens Hospital Medical Center /ID# 209697
🇺🇸Cincinnati, Ohio, United States
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
🇵🇷Bayamon, Puerto Rico
Mindful Medical Research /ID# 204488
🇵🇷San Juan, Puerto Rico
Hospital Universitario La Paz /ID# 203927
🇪🇸Madrid, Spain
Hospital Universitario y Politecnico La Fe /ID# 203914
🇪🇸Valencia, Spain
Boston Children's Hospital /ID# 202993
🇺🇸Boston, Massachusetts, United States
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
🇩🇪Hamburg, Germany
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia /ID# 209617
🇺🇸Philadelphia, Pennsylvania, United States
Duplicate_University of Louisville /ID# 202896
🇺🇸Louisville, Kentucky, United States
St. Josef-Stift Sendenhorst /ID# 244740
🇩🇪Sendenhorst, Nordrhein-Westfalen, Germany
Miyagi Children's Hospital /ID# 246734
🇯🇵Sendai-shi, Miyagi, Japan
PRI - Pediatric Rheumatology Research Institute /ID# 205954
🇩🇪Bad Bramstedt, Schleswig-Holstein, Germany
Helios Klinikum Berlin-Buch /ID# 206859
🇩🇪Berlin, Germany
Queen Silvia Children's Hosp /ID# 251145
🇸🇪Gothenburg, Vastra Gotalands Lan, Sweden
Asklepios Klinik Sankt Augustin /ID# 203264
🇩🇪Sankt Augustin, Germany
The Chaim Sheba Medical Center /ID# 222370
🇮🇱Ramat Gan, Tel-Aviv, Israel
Niigata University Medical & Dental Hospital /ID# 247246
🇯🇵Niigata-shi, Niigata, Japan
Hospital Universitario Ramon y Cajal /ID# 203917
🇪🇸Madrid, Spain
Children's Hospital of Pittsburgh of UPMC /ID# 202994
🇺🇸Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital /ID# 203003
🇺🇸Seattle, Washington, United States
Randall Children's Hospital /ID# 213609
🇺🇸Portland, Oregon, United States
British Columbia Children and Women's Hospital and Health Centre /ID# 251736
🇨🇦Vancouver, British Columbia, Canada
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835
🇮🇹Rome, Roma, Italy
Tokyo Medical And Dental University Hospital /ID# 246500
🇯🇵Bunkyo-ku, Tokyo, Japan
Hospital Infantil Universitario Nino Jesus /ID# 206466
🇪🇸Madrid, Spain
GCM Medical Group PSC /ID# 211702
🇵🇷San Juan, Puerto Rico
Hyogo Prefectural Kobe Children's Hospital /ID# 246582
🇯🇵Kobe-shi, Hyogo, Japan
Aichi Children's Health and Medical Center /ID# 248327
🇯🇵Obu-shi, Aichi, Japan
Kagoshima University Hospital /ID# 246501
🇯🇵Kagoshima-shi, Kagoshima, Japan
Montreal Children's Hospital /ID# 251252
🇨🇦Montreal, Quebec, Canada
St. Marianna University Hospital /ID# 246478
🇯🇵Kawasaki-shi, Kanagawa, Japan
Alberta Children's Hospital /ID# 251738
🇨🇦Calgary, Alberta, Canada
Semmelweis Egyetem /ID# 208970
🇭🇺Budapest, Hungary
Hospital Sant Joan de Deu /ID# 203915
🇪🇸Esplugues de Llobregat, Barcelona, Spain