A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA
- Conditions
- Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)MedDRA version: 14.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2008-005476-27-Outside-EU/EEA
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 84
• 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 for at least 3 days with accompanying symptoms
• Active disease at the time of enrollment defined as follows:
? At least 2 joints with active arthritis (using ACR definition of active joint)
? Documented spiking, intermittent fever (body temperature > 38oC) for at least 1 day during screening period within 1 week before first study drug dose
? C-reactive protein > 30 mg/L (normal range < 10 mg/L)
• No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
? Stable dose of methotrexate for at least 8 weeks
? Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks
? Stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 56
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
• Patients with active bacterial, fungal or viral infections at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study will assess the initial efficacy and safety of canakinumab over a 4 week period in patients with SJIA having a flare. Response to treatment will be according to the adapted ACR Pediatric 30 criteria at Day 15.;Secondary Objective: ;Primary end point(s): Proportion of patients who meet the adapted ACR pediatric 30 criteria;Timepoint(s) of evaluation of this end point: Day 15
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Proportion of patients achieving the adapted ACR Pediatric 30 criteria <br>2. Proportion of patients achieving the adapted ACR Pediatric 50/70/90/100 criteria<br>3. Change in patient's pain intensity as assessed on a 100-mm visual analog scale<br>4. Proportion of patients who show clinical signs of response<br>5. Change in health-related quality of life over time by use of the CHQ <br>6. Change in disability over time by use of the CHAQ ;Timepoint(s) of evaluation of this end point: 1. Day 29<br>2. During the 4 week study period<br>3. During the 4 week study period<br>4. Day 3<br>5. During the 4 week study period<br>6. During the 4 week study period