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
- EUCTR2008-005479-82-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
- 177
•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 the 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 prior to the screening visit, and/or folic/folinic acid per standard medical practice
? Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
? 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: 171
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
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
• Risk factors for tuberculosis
• Patients with active or recurrent bacterial, fungal or viral infection 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 two-part study will assess the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.;Secondary Objective: ;Primary end point(s): 1. Time to flare in Part II<br>2. Proportion of patients who were on steroids at entry into Part I and who were able to taper steroid as per protocol.;Timepoint(s) of evaluation of this end point: 1. During part II, which is event driven (total duration - TBD)<br>2. Maximum duration of Part I 32 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Maintenance of adapted ACR Pediatric 30/50/70/90/100 criteria during Part II<br>2. Change in disability over time by CHAQ<br>3. Change in health related quality of life over time by CHQ-PF50<br>4. Proportion of patients who reached a steroid dose < or = 0.2 mg/kg at end of Part Ic<br>5. Steroid level at end of Part Ic and change from baseline to end of Part Ic;Timepoint(s) of evaluation of this end point: 1. During part II, which is event driven (total duration - TBD)<br>2. Over the length of the event driven study (total duration - TBD)<br>3. During part II, which is event driven (total duration - TBD)<br>4. Maximum duration of Part I 32 weeks<br>5. Maximum duration of Part I 32 weeks