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
Main Objective: To evaluate if the proportion of patients in clinical remission on<br>canakinumab 4mg/kg (+/- concomitant NSAID only) who are able<br>to remain on a reduced canakinumab dose (2mg/kg every 4 weeks)<br>or prolonged canakinumab dose interval (4mg/kg every 8 weeks)<br>for at least 24 consecutive weeks is at least 40% in either treatment<br>arm (Part II).;Secondary Objective: To assess the long-term safety and tolerability of canakinumab<br>(Parts I and II).;Primary end point(s): Proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who are able to remain at a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg every 8 weeks) for at least 24 consecutive weeks;Timepoint(s) of evaluation of this end point: 24 weeks from randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): long-term safety and tolerability of canakinumab;Timepoint(s) of evaluation of this end point: Duration of trial

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

Recruitment & Eligibility

Study & Design

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