ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Inclusion Criteria- Cohort 1:
• Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for =18 years of age must be obtained before any study related activity or assessment is performed.
• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for SJIA and have inactive disease at the last visit in Study CACZ885G2301E1 .

Inclusion Criteria- Cohort 2:
• Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for = 18 years of age must be obtained before any study related activity or assessment is performed.
• Male and female patients aged = 2 to < 20 years at the time of the screening visit
• Confirmed diagnosis of SJIA as per ILAR definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age:
• Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following:
• Evanescent non-fixed erythematous rash,
• Generalized lymph node enlargement,
• Hepatomegaly and/ or splenomegaly,
• Serositis
• Active SJIA at the time of baseline visit defined as having 2 or more of the following:
• Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose,
• At least 2 joints with active arthritis (using ACR definition of active joint),
• C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L),
• Rash,
• Serositis,
• Lymphadenopathy,
• Hepatosplenomegaly
• Patient’s willingness to discontinue anakinra, rilonacept, tocilizumab, abatacept or other experimental or approved drug under close monitoring (Please refer to Cohort 2 exclusion criteria #16 for washout period.)
• Negative QuantiFERON (QF) test (or, if required by local guidelines, negative Purified Protein Derivative [PPD] test [< 5 mm induration]) at screening or within 1 month prior to the screening visit.
Are the trial subjects under 18? yes
Number of subjects for this age range: 163
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria – Cohort 1 and Cohort 2:
• Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Female patients of child-bearing potential, defined as all females physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods defined in protocol.
• History of hypersensitivity to study drug or to biologics.
• With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
• History or evidence of tuberculosis (TB) (active or latent) infection or one of the risk factors for tuberculosis (TB) as defined in protocol.
• With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and €/ or places the patient at unacceptable risk for participation in an immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome.
• With neutropenia (absolute neutrophil count < 1500/mm3) at screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab

Recruitment & Eligibility

Study & Design

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