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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000715-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants of age group 12 to <18 years receiving dose A | Experimental | Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent) as described in the protocol. |
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| Participants of age group 12 to <18 years receiving dose B | Experimental | Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent) as described in the protocol. |
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| Participants of age group 6 to <12 years receiving dose A | Experimental | Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent) as described in the protocol. |
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| Participants of age group 2 to <6 years receiving dose A | Experimental | Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent) as described in the protocol. |
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| Participants of age group 2 to <18 years receiving dose A | Experimental | Participants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Upadacitinib is administered as an oral solution or tablet as described in protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. | Up to approximately 156 weeks |
| Part 1: Maximum observed plasma concentration (Cmax) | Cmax is defined as the maximum observed plasma concentration for upadacitinib. | Day 7 |
| Part 1: Time to maximum observed plasma concentration (Tmax) | Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib. | Day 7 |
| Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau) | The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma. | Day 7 |
| Part 1: Apparent oral clearance at steady state (CL/F) | Clearance is defined as the volume of plasma cleared of the drug per unit time. | Day 7 |
| Part 1: Half-life | Half life of updadacitinib will be determined using non-compartmental method. | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162 | Chicago | Illinois | 60611 | United States | ||
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| Duplicate_University of Louisville /ID# 202896 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Boston Children's Hospital /ID# 202993 | Boston | Massachusetts | 02115 | United States |
| Cincinnati Childrens Hospital Medical Center /ID# 209697 | Cincinnati | Ohio | 45229 | United States |
| Randall Children's Hospital /ID# 213609 | Portland | Oregon | 97227-1654 | United States |
| Children's Hospital of Philadelphia /ID# 209617 | Philadelphia | Pennsylvania | 19146-2305 | United States |
| Children's Hospital of Pittsburgh of UPMC /ID# 202994 | Pittsburgh | Pennsylvania | 15224-1334 | United States |
| Seattle Children's Hospital /ID# 203003 | Seattle | Washington | 98105 | United States |
| Alberta Children's Hospital /ID# 251738 | Calgary | Alberta | T3B 6A8 | Canada |
| British Columbia Children and Women's Hospital and Health Centre /ID# 251736 | Vancouver | British Columbia | V6H 3N1 | Canada |
| Duplicate_McGill University Health Centre /ID# 251252 | Montreal | Quebec | H4A 3J1 | Canada |
| Asklepios Klinik Sankt Augustin /ID# 203264 | Sankt Augustin | North Rhine-Westphalia | 53757 | Germany |
| St. Josef-Stift Sendenhorst /ID# 244740 | Sendenhorst | North Rhine-Westphalia | 48324 | Germany |
| PRI - Pediatric Rheumatology Research Institute /ID# 205954 | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| Helios Klinikum Berlin-Buch /ID# 206859 | Berlin | 13125 | Germany |
| Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571 | Hamburg | 22081 | Germany |
| Semmelweis Egyetem /ID# 208970 | Budapest | 1085 | Hungary |
| The Chaim Sheba Medical Center /ID# 222370 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Ospedale Pediatrico Bambino Gesù /ID# 203835 | Rome | Roma | 00165 | Italy |
| Aichi Children's Health and Medical Center /ID# 248327 | Obu-shi | Aichi-ken | 474-8710 | Japan |
| Hyogo Prefectural Kobe Children's Hospital /ID# 246582 | Kobe | Hyōgo | 650-0047 | Japan |
| Kagoshima University Hospital /ID# 246501 | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| St Marianna University School Of Medicine /ID# 246478 | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Miyagi Children's Hospital /ID# 246734 | Sendai | Miyagi | 989-3126 | Japan |
| Niigata University Medical & Dental Hospital /ID# 247246 | Niigata | Niigata | 951-8520 | Japan |
| Institute of Science Tokyo Hospital /ID# 246500 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406 | Bayamón | 00959 | Puerto Rico |
| GCM Medical Group PSC /ID# 211702 | San Juan | 00917-3104 | Puerto Rico |
| Mindful Medical Research /ID# 204488 | San Juan | 00918-3756 | Puerto Rico |
| Hospital Sant Joan de Deu /ID# 203915 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Infantil Universitario Nino Jesus /ID# 206466 | Madrid | 28009 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 203917 | Madrid | 28034 | Spain |
| Hospital Universitario La Paz /ID# 203927 | Madrid | 28046 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 203914 | Valencia | 46026 | Spain |
| Queen Silvia Children's Hosp /ID# 251145 | Gothenburg | Västra Götaland County | 416 85 | Sweden |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
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