Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Systemic Juvenile Idiopathic Arthritis

Treatments: Drug: Canakinumab; Drug: Placebo

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00886769

EudraCT: 2008-005476-27

CACZ885G2305

Details and patient eligibility

About

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Enrollment: 84 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with 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 nonfixed erythematous rash,
   • generalized lymph node enlargement,
   • hepatomegaly and/ or splenomegaly,
   • serositis

2. Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age

3. Male and female patients aged ≥ 2 to < 20 years of age

4. Active disease at the time of enrollment defined as follows:

   • At least 2 joints with active arthritis
   • Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
   • C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)

5. Naïve to canakinumab

6. Other protocol defined inclusion criteria may apply

Exclusion criteria

Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:

1. Pregnant or nursing (lactating) female patients
2. Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
3. History of hypersensitivity to study drug or to biologics.
4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
5. With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
6. Other protocol defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Canakinumab

Experimental group

Description:

Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.

Treatment:

Drug: Canakinumab

Placebo

Placebo Comparator group

Description:

Patients received a single dose matching placebo of canakinumab on day 1.

Treatment:

Drug: Placebo