A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
