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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005212-98 | EudraCT Number |
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This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline up to 3 years | |
| Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest | Baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Health Assessment Questionnaire (CHAQ) Score | Baseline up to 3 years | |
| Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission | Baseline up to 3 years |
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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 | ||
| University of Chicago Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38552315 | Derived | Brunner HI, Ruperto N, Ramanan AV, Horneff G, Minden K, Calvo Penades I, Alexeeva E, Cleary G, Stern SM, Kone-Paut I, Maldonado Velazquez MDR, Rabinovich CE, Remesal A, Silva CA, Nikishina I, Zucchetto M, Brockwell L, Gordon O, Nagel S, De Benedetti F; PRINTO and PRCSG Investigators. Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Sep 1;63(9):2535-2546. doi: 10.1093/rheumatology/keae180. |
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|
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Hackensack University Medical Center; Pediatric Rheumatology | Hackensack | New Jersey | 07601 | United States |
| Duke University | Durham | North Carolina | 27705 | 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 |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | 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 | C1270AAN | Argentina |
| Hospital de Ninos de la Santisima Trinidad; Hematología | Córdoba | X5000XAF | Argentina |
| Westmead Hospital; Paediatric Rheumatology | Westmead | New South Wales | 2145 | Australia |
| Royal Children'S Hospital; Paediatric Rheumatology | Parkville | Victoria | 3052 | Australia |
| Universidade Federal de Sao Paulo - UNIFES | São Paulo | São Paulo | 04026-000 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-900 | Brazil |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| The 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 für Allgemeine Pädiatrie und Neonatologie | Sankt Augustin | 53757 | Germany |
| Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina | Rome | Lazio | 00165 | Italy |
| Hospital Infantil de México "Federico Gomez"; Rheumatology | México | 06720 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria | Monterrey | 64460 | Mexico |
| 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 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; Rheumatology Department | Bristol | BS2 8BJ | United Kingdom |
| Alder Hey Children's NHS Foundation Trust | Liverpool | L12 2AP | 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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