A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)
16 de mayo de 2017 actualizado por: Hoffmann-La Roche
A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13353
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Freiburg, Alemania, 79106
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Sankt Augustin, Alemania, 53757
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Buenos Aires, Argentina, 1270
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New South Wales
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Westmead, New South Wales, Australia, 2145
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Victoria
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Parkville, Victoria, Australia, 3052
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RJ
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Rio de Janeiro, RJ, Brasil, 20551-030
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Rio de Janeiro, RJ, Brasil, 21941-912
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SP
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Sao Paulo, SP, Brasil, 05403-000
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Sao Paulo, SP, Brasil, 22793-080
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Alberta
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Calgary, Alberta, Canadá, T3B 6A8
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
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Toronto, Ontario, Canadá, M5G 1X8
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Madrid, España, 28046
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Madrid, España, 28034
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Barcelona
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Esplugas de Llobregat, Barcelona, España, 08950
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
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Chicago, Illinois, Estados Unidos, 60611
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
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Durham, North Carolina, Estados Unidos, 27710
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229-3039
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74135
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Utah
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Salt Lake City, Utah, Estados Unidos, 84109
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Washington
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Seattle, Washington, Estados Unidos, 98105
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Moscow, Federación Rusa, 115522
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Moscow, Federación Rusa, 119991
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Le Kremlin Bicêtre, Francia, 94275
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Lazio
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Roma, Lazio, Italia, 00165
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Liguria
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Genova, Liguria, Italia, 16147
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Toscana
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Firenze, Toscana, Italia, 50139
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Monterrey, México, 64460
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Bristol, Reino Unido, BS2 8BJ
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Liverpool, Reino Unido, L12 2AP
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 año a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
- Diagnosis of pJIA according to International League of Associations for Rheumatology classification
- Rheumatoid factor (RF)-positive pJIA
- RF-negative pJIA
- Extended oligoarticular JIA with a polyarticular course
- History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
- Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
- Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator
- Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the time of the screening visit
- Females who are pregnant, lactating, or intending to become pregnant during study conduct
- Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
- Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
- History of alcohol, drug, or chemical abuse within 6 months of screening
- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
- Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
- History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
- History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
- History of or current cancer or lymphoma
- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
- Active uveitis at screening
- Inadequate hematologic, renal or liver function
- Prior stem cell transplant at any time
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: TCZ SC 162 mg Q3W
Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Otros nombres:
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Experimental: TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Minimum Serum Concentration (Cmin) of TCZ at Steady State
Periodo de tiempo: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
Periodo de tiempo: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
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Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Maximum Serum Concentration (Cmax) of TCZ at Steady State
Periodo de tiempo: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Periodo de tiempo: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset.
It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in Soluble IL-6 Receptor Levels
Periodo de tiempo: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in C-Reactive Protein (CRP) Levels
Periodo de tiempo: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Periodo de tiempo: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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The ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline indicates improvement.
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Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
Periodo de tiempo: Baseline up to Week 52
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Baseline up to Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2013
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
14 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2013
Publicado por primera vez (Estimar)
22 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
16 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WA28117
- 2012-003486-18 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Artritis reumatoide juvenil idiopática
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Charles Drew University of Medicine and ScienceLos Angeles County Department of Public HealthRetiradoEquidad en salud | Investigación Acción Participativa Juvenil | Salud mental juvenil
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University of AarhusAarhus University HospitalTerminadoArtritis reumatoide juvenil poliarticular | Artritis idiopática juvenil sistémica | Artritis Idiopática Juvenil, OligoartritisDinamarca
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University of Sao Paulo General HospitalAún no reclutandoArtritis reumatoide juvenil idiopática | Artritis reumatoide juvenil | Artritis juvenilBrasil
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Montana State UniversityTerminadoCompromiso juvenilEstados Unidos
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PfizerReclutamientoArtritis idiopática juvenil poliarticular | Artritis Psoriásica JuvenilCorea del Sur
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citiesRISEAfrican Population and Health Research Center; Schizophrenia Research Foundation...TerminadoSalud mental juvenilIndia, Kenia
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Bangladesh Medical UniversityTerminadoArtritis reumatoide juvenil idiopática | Artritis idiopática juvenil poliarticular | Artritis Idiopática Juvenil Poliarticular RefractariaBangladesh
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University of the PunjabReclutamientoLa delincuencia juvenilPakistán
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Ondokuz Mayıs UniversityAún no reclutando
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Tufts Medical CenterHoffmann-La RocheTerminadoArtritis Reumatoide Juvenil | Enfermedad de Still, inicio juvenilEstados Unidos
Ensayos clínicos sobre Tocilizumab
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Icahn School of Medicine at Mount SinaiReclutamiento
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University of ChicagoReclutamiento
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Assistance Publique - Hôpitaux de ParisFresenius AGAún no reclutandoEnfermedad por depósito de pirofosfato de calcioFrancia
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Hoffmann-La RocheReclutamiento
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Nationwide Children's HospitalChildren's Hospital ColoradoReclutamientoCraneofaringioma Adamantinomatoso | Craneofaringioma Adamantinomatoso RecurrenteEstados Unidos, Australia, Canadá
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Queen's Medical CenterTerminadoCOVID-19Estados Unidos
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Hoffmann-La RocheTerminadoArtritis reumatoide juvenil idiopáticaFrancia
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Capital Medical UniversityReclutamiento
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Capital Medical UniversityActivo, no reclutando
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University of Colorado, DenverNational Cancer Institute (NCI); National Institutes of Health (NIH)Activo, no reclutando