Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA (NCT02396212) | Clinical Trial Compass
CompletedPhase 3
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Japan19 participantsStarted 2015-05-07
Plain-language summary
This was 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 supported a registration submission of canakinumab in the indication of SJIA in Japan.
Who can participate
Age range2 Years – 19 Years
SexALL
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Inclusion Criteria
\- Confirmed diagnosis of SJIA as per International League Against Rheumatism (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
* C-Reactive Protein (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 part…
What they're measuring
1
Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Timeframe: Week 8
2
Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully