Name: Estudio de fase Ib, abierto, multicéntrico, para investigar la farmacocinética, farmacodinámica y seguridad de tocilizumab tras la administración subcutánea en pacientes con artritis idiopática juvenil poliarticular.
Published: 2026-03-15T21:58:18.017Z

Este ensayo clínico abierto y multicéntrico evaluó la farmacocinética, farmacodinámica y seguridad de TCZ administrado por vía subcutánea (SC) en participantes con AIJp.

Elegibilidad

Edad mínima: 1 YearEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Estudio de fase Ib, abierto, multicéntrico, para investigar la farmacocinética, farmacodinámica y seguridad de tocilizumab tras la administración subcutánea en pacientes con artritis idiopática juvenil poliarticular.

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Tocilizumab

Ubicaciones

Patrocinadores