A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND
- Conditions
- Systemic Juvenile Idiopathic Arthritis (SJIA)MedDRA version: 12.0Level: LLTClassification code 10059177Term: Juvenile arthritis
- Registration Number
- EUCTR2008-005479-82-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 214
Inclusion criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Parents or legal guardians written informed consent and childs assent, if appropriate, or patients informed consent for ≥ 18 years of age before any study related activity is performed. 2. Male and female patients aged ≥ 2 to < 20 years at the time of the screening visit 3. Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al 2004) that must have occurred at least 2 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: Evanescent nonfixed erythematous rash, Generalized lymph node enlargement, Hepatomegaly and/ or splenomegaly, Serositis 4. 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 > 38C) for at least 3 days during the screening period (minimum duration of screening 3 days) before first canakinumab/placebo dose C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) PLS SEE PROTOCOL
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria Patients who fulfill one or more of the following criteria will not be eligible for inclusion in this study: 1. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ mL) at screening visit 2. Female patients having reached sexual maturity, i.e. being physiologically capable of becoming pregnant UNLESS they are: female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and/or using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception should be maintained throughout the study and for 2 months after study drug discontinuation. 3. History of hypersensitivity to study drug or to biologics. 4. Biologic features of MAS [such as hemorrhages, central nervous system dysfunction, hepatomegaly, plasma fibrinogen level < 2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet count, increased aspartate transaminase, hyperferritinemia (Ravelli, Magni-Manzoni and Pistorio 2005)] at screening or a history of recurrent pericarditis, myocarditis, serositis and/ or biologic features of MAS over the last 6 months 5. 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 6. Any of the risk factors for tuberculosis (TB) such as: History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection); health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last year 7. 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 in an immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Feltys syndrome. 8. With significant medical conditions, which in the opinion of the Investigator will exclude the patient from the study (can be discussed on a case by case basis with Novartis) 9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases 10. History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia) 11. Uncontrolled hypertension PLS SEE PROTOCOL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method