Resumen

PARTE 1: Los participantes de la Parte 1 (fase de inclusión) del estudio recibirán tocilizumab (TCZ) (RoActemra/Actemra) 12 miligramos por kilogramo (mg/kg) u 8 mg/kg por vía intravenosa (IV) cada 2 semanas (Q2W) durante hasta 24 semanas. Los participantes que experimenten una anomalía de laboratorio durante la Parte 1 podrán ser elegibles para pasar a la Parte 2 del estudio. PARTE 2: Este estudio abierto de fase IV evaluará la eficacia, seguridad, farmacocinética, farmacodinamia e inmunogenicidad de tocilizumab con frecuencia de dosis reducida en participantes con artritis idiopática juvenil sistémica adecuadamente controlada que hayan experimentado una anomalía de laboratorio con la dosificación de tocilizumab dos veces por semana, que desde entonces se haya resuelto. Los participantes recibirán tocilizumab 12 mg/kg u 8 mg/kg por vía intravenosa cada 3 semanas. Después de 5 infusiones consecutivas, los participantes que experimenten un evento de neutropenia, trombocitopenia o anomalía de enzimas hepáticas pasarán a la administración de tocilizumab cada 4 semanas. El tiempo anticipado de tratamiento en el estudio es de 52 semanas.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

PART 1 and 2
Children 2 to 17 years of age inclusive at screening
Systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) classification (2001) and sJIA symptoms lasting for at least 1 month since diagnosis of sJIA
Must meet one of the following:
Not receiving methotrexate (MTX) or discontinued MTX at least 4 weeks prior to baseline visit, or
Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of less than or equals (\</=) 20 milligrams per meter square (mg/m\^2) for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care
Participants entering Part 1 who are naive to TCZ therapy must also meet the following inclusion criterion:
History of inadequate clinical response (in the opinion of the treating physician) to Non steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids PART 2
Juvenile Arthritis Disease Activity Score (JADAS) -71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline
Neutropenia, thrombocytopenia, or elevated Alanine transaminase/Aspartate transaminase (ALT/AST) previously experienced on the labeled dose (Q2W) of RoActemra/Actemra at any time
Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to baseline visit at no more than 10 milligrams per day (mg/day) or 0.2 miiligrams per kilogram per day (mg/kg/day), whichever is less
Not taking (NSAIDs), or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose

Criterios de exclusión

Wheelchair bound or bedridden
Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA
Pregnant or lactating, or intending to become pregnant during study conduct and up to 6 months after the last administration of study drug
Any significant concurrent medical or surgical condition which would jeopardize the participant's safety or ability to complete the trial
History of significant allergic or infusion reactions to prior TCZ infusion, and/or presence of anti-TCZ antibodies at screening
Inborn conditions characterized by a compromised immune system
Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune compromise
History of alcohol, drug, or chemical abuse within 6 months of screening
Evidence of serious uncontrolled concomitant diseases, including but not limited to the nervous, renal, hepatic, or endocrine systems
Any active acute, subacute, chronic or recurrent bacterial, viral, or systemic fungal infection
History of atypical tuberculosis (TB)
Active TB requiring treatment within 2 years prior to the screening visit
Positive purified protein derivative (PPD) at screening
Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completing within 4 weeks of the screening visit or oral antibiotics completing within 2 weeks of the screening visit
History of reactivation or new onset of a systemic infection within 2 months of the screening visit
Positive for hepatitis B or hepatitis C infection
Chronic hepatitis, viral or pulmonary disease
Significant cardiac or pulmonary disease
History of or current cancer or lymphoma
Uncontrolled diabetes mellitus
History of or concurrent serious gastrointestinal disorders
History of macrophage activation syndrome (MAS) within 3 months prior to screening visit

Estudio de fase IV para evaluar la disminución de la frecuencia de dosis en pacientes con artritis juvenil sistémica (AJS) que presentan anomalías de laboratorio durante el tratamiento con tocilizumab

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Tocilizumab

Ubicaciones

Hospital Gral de Niños Pedro Elizalde

Hospital Dr. Humberto Notti

Patrocinadores