Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Juvenile Idiopathic Arthritis
Intervention: Canakinumab (Biological)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact: Novartis Pharmaceuticals, Phone: +81337978748
Summary
This is a phase III study designed to provide efficacy and safety data for canakinumab
administered for at least 48 weeks as subcutaneous (s. c.) injection every 4 weeks (q4wk) in
Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)
data at Week 28 and 48 from this study will support a registration submission of canakinumab
in the indication of SJIA in Japan.
Clinical Details
Official title: An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteriaProportion of patients with canakinumab treatment who were able to taper corticosteroids successfully
Secondary outcome: Proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over timeChange from baseline in components of the adapted ACR pediatric criteria of canakinumab over time Proportion of patients who had flares with canakinumab treatment over time Proportion of patients who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time Changes from baseline in CRP levels with canakinumab treatment over time Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully over time Corticosteroids dose reduction with canakinumab treatment over time Number and percentage of patients with adverse events Percentage of patients with notable abnormalities in laboratory parameters newly occurred after baseline Percentage of patients with notable abnormalities in vital sign newly occurred after baseline Serum concentration of canakinumab and total IL-1 beta Immunogenicity of canakinumab
Eligibility
Minimum age: 2 Years.
Maximum age: 19 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
- Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al. 2004) that must have
occurred at least 3 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: Rash due to SJIA,lymphadenopathy, Hepatomegaly/Splenomegaly,
Serositis
- Active disease at the time of baseline 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 epoch and within 1 week before first canakinumab dose
- CRP > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))
- Negative TB screen (Chest X-ray and T-SPOT test)
Exclusion Criteria:
- 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. Patients with resolved/previous
hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody
and/or anti-HBc antibody).
- 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.
- With neutropenia (absolute neutrophil count < 1500/mm3) at screening.
Locations and Contacts
Novartis Pharmaceuticals, Phone: +81337978748
Novartis Investigative Site, Obu-city, Aichi 474-8710, Japan; Not yet recruiting
Novartis Investigative Site, Kobe-city, Hyogo 654-0081, Japan; Not yet recruiting
Novartis Investigative Site, Kanazawa-city, Ishikawa 920-8641, Japan; Recruiting
Novartis Investigative Site, Kagoshima-city, Kagoshima 890-8520, Japan; Recruiting
Novartis Investigative Site, Yokohama-city, Kanagawa 232-8555, Japan; Not yet recruiting
Novartis Investigative Site, Yokohama-city, Kanagawa 236-0004, Japan; Not yet recruiting
Novartis Investigative Site, Sendai-city, Miyagi 989-3126, Japan; Recruiting
Novartis Investigative Site, Bunkyo-ku, Tokyo 113-8603, Japan; Not yet recruiting
Additional Information
Starting date: May 2015
Last updated: May 5, 2015
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