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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003490-26 | EudraCT Number |
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This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Participants will receive SC dose of tocilizumab based on body weight; participants with <30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants =>30 kg will receive 162 mg of tocilizumab QW, for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Subcutaneous 162 mg dose QW or Q2W for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab | Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364 | |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab | Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364 | |
| Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab | Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Serum Interleukin-6 (IL6) Levels | Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364 | |
| Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| Connecticut Children's Medical Center; 5E Clinical Trials Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33506875 | Derived | Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047. |
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| Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364 |
| Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels | Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364 |
| Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR) | Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364 |
| Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies | Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364 |
| Safety: Percentage of Participants with At Least 1 Adverse Event | 57 weeks |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology | Chicago | Illinois | 60611 | United States |
| The University of Chicago;Department of Pediatrics | Chicago | Illinois | 60649 | United States |
| Hackensack University Medical Center; Pediatric Rheumatology | Hackensack | New Jersey | 07601 | United States |
| Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics | Charlotte | North Carolina | 28203 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children'S Hospital Medical Center; Division of Rheumatology | Cincinnati | Ohio | 45229-3039 | United States |
| Cleveland Clinic Fndn | Cleveland | Ohio | 44195 | United States |
| University of Utah; Immunology/Rheumatology/Allergy | Salt Lake City | Utah | 84109 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Hospital Gral de Niños Pedro Elizalde | Buenos Aires | 1270 | Argentina |
| Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil | Córdoba | 5000 | Argentina |
| Westmead Hospital; Paediatric Rheumatology | Westmead | New South Wales | 2145 | Australia |
| Royal Children'S Hospital; Paediatric Rheumatology | Parkville | Victoria | 3052 | Australia |
| Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia | São Paulo | São Paulo | 05403-000 | Brazil |
| Universidade Federal de Sao Paulo - UNIFESP | São Paulo | São Paulo | 22793-080 | Brazil |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Children'S Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| CH de Bicêtre; Pediatrie Generale | Le Kremlin-Bicêtre | 94275 | France |
| Charité Campus; Virchow Klinikum Berlin | Berlin | 13353 | Germany |
| Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie | Freiburg im Breisgau | 79106 | Germany |
| Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie | Sankt Augustin | 53757 | Germany |
| Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina | Rome | Lazio | 00165 | Italy |
| Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS | Genoa | Liguria | 16147 | Italy |
| Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1° | Florence | Tuscany | 50139 | Italy |
| Hospital Infantil de México "Federico Gomez"; Rheumatology | México | 06720 | Mexico |
| Cliditer SA de CV | Miexico City | 06700 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria | Monterrey | 64460 | Mexico |
| FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences | Moscow | 115522 | Russia |
| SI Sceintific children health center RAMS | Moscow | 119991 | Russia |
| Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica | Esplugas de Llobregat | Barcelona | 08950 | Spain |
| Hospital Infantil Universitario Niño Jesus, Servicio Reumatologia | Madrid | 28009 | Spain |
| Hospital Ramon y Cajal ; Servicio de Reumatologia | Madrid | 28034 | Spain |
| Hospital de La Paz; Unidad de Reumatologia Pediatrica | Madrid | 28046 | Spain |
| Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica | Valencia | 46026 | Spain |
| Bristol Royal Hospital For Children | Bristol | BS2 8BJ | United Kingdom |
| Alder Hey Children's NHS Foundation Trust | Liverpool | L12 2AP | United Kingdom |
| Great Ormond Street Hospital; Somers Clinical Research Facility | London | WC1N 3JH | United Kingdom |
| Nottingham Children's Hospital | Nottingham | NG7 2UH | United Kingdom |
| 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 |
|---|---|
| C502936 | tocilizumab |
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