An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.



Status:Completed
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:2 - 19
Updated:3/28/2019
Start Date:September 2009
End Date:December 2014

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An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

This open-label extension study will permit patients with Systemic Juvenile Idiopathic
Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab
treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg
s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or
when study CACZ885G2402 is in place at their study center or around March 2013, whichever
occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2
mg/kg s.c. every 4 weeks.


Inclusion criteria:

- Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric
30 response 15 days after their initial dose of canakinumab but clinically
deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained
after Day 15 and intervention is deemed necessary by the investigator, or Patients in
study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because
they were not able to meet the corticosteroid entry criteria , or Responder patients
in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301
patients who were responders in Part I but experienced a flare in Part II.

- Treatment-naïve patients need to meet the following criteria:

- 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

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

- Active disease at the time of enrollment 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

- AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Rash
Serositis Lymphadenopathy Hepatosplenomegaly

- Naïve to canakinumab

Other protocol-defined inclusion criteria may apply

Exclusion criteria:

- History of allergy or hypersensitivity to study drug

- With active or recurrent bacterial, fungal or viral infections at time of enrollment

Other protocol inclusion/exclusion criteria may apply
We found this trial at
7
sites
Boston, Massachusetts 02118
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Caba, Buenos Aires
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Caba,
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Columbus, Ohio 43205
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Columbus, OH
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Los Angeles, California 90095
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, KY
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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