An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

Who is this study for? Child to young adult patients with Rheumatoid Factor-Positive or Negative Polyarticular Juvenile Idiopathic Arthritis
What treatments are being studied? Upadacitinib
Status: Active_not_recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
Chicago
Kentucky
Duplicate_University of Louisville /ID# 202896
Louisville
Massachusetts
Boston Children's Hospital /ID# 202993
Boston
Ohio
Cincinnati Childrens Hospital Medical Center /ID# 209697
Cincinnati
Oregon
Randall Children's Hospital /ID# 213609
Portland
Pennsylvania
Children's Hospital of Philadelphia /ID# 209617
Philadelphia
Children's Hospital of Pittsburgh of UPMC /ID# 202994
Pittsburgh
Washington
Seattle Children's Hospital /ID# 203003
Seattle
Other Locations
Canada
Alberta Children's Hospital /ID# 251738
Calgary
Duplicate_McGill University Health Centre /ID# 251252
Montreal
British Columbia Children and Women's Hospital and Health Centre /ID# 251736
Vancouver
Germany
PRI - Pediatric Rheumatology Research Institute /ID# 205954
Bad Bramstedt
Helios Klinikum Berlin-Buch /ID# 206859
Berlin
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
Hamburg
Asklepios Klinik Sankt Augustin /ID# 203264
Sankt Augustin
St. Josef-Stift Sendenhorst /ID# 244740
Sendenhorst
Hungary
Semmelweis Egyetem /ID# 208970
Budapest
Israel
The Chaim Sheba Medical Center /ID# 222370
Ramat Gan
Italy
Ospedale Pediatrico Bambino Gesù /ID# 203835
Rome
Japan
Institute of Science Tokyo Hospital /ID# 246500
Bunkyo-ku
Kagoshima University Hospital /ID# 246501
Kagoshima
St Marianna University School Of Medicine /ID# 246478
Kawasaki-shi
Hyogo Prefectural Kobe Children's Hospital /ID# 246582
Kobe
Niigata University Medical & Dental Hospital /ID# 247246
Niigata
Aichi Children's Health and Medical Center /ID# 248327
Obu-shi
Miyagi Children's Hospital /ID# 246734
Sendai
Puerto Rico
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
Bayamón
GCM Medical Group PSC /ID# 211702
San Juan
Mindful Medical Research /ID# 204488
San Juan
Spain
Hospital Sant Joan de Deu /ID# 203915
Esplugues De Llobregat
Hospital Infantil Universitario Nino Jesus /ID# 206466
Madrid
Hospital Universitario La Paz /ID# 203927
Madrid
Hospital Universitario Ramon y Cajal /ID# 203917
Madrid
Hospital Universitario y Politecnico La Fe /ID# 203914
Valencia
Sweden
Queen Silvia Children's Hosp /ID# 251145
Gothenburg
Time Frame
Start Date: 2019-06-24
Completion Date: 2027-05
Participants
Target number of participants: 124
Treatments
Experimental: Participants of age group 12 to <18 years receiving dose A
Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Experimental: Participants of age group 12 to <18 years receiving dose B
Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
Experimental: Participants of age group 6 to <12 years receiving dose A
Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Experimental: Participants of age group 2 to <6 years receiving dose A
Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Experimental: Participants of age group 2 to <18 years receiving dose A
Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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