inflammation in the joints rheumathism
Conditions
Interventions
Patients will receive a single dose of canakinumab (4 mg/kg) or placebo at Day
1. The maximal total single dose of canakinumab allowed is 300 mg. The maximal
dose which can be administered per singl
Sponsors
Novartis
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Parent*s or legal guardian*s written informed consent and child*s assent, if appropriate, or patient*s informed consent for * 18 years of age before any study related activity is performed. 2. Male and female patients aged * 2 to 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose * C-reactive protein > 30 mg/L (normal range
Exclusion criteria
Exclusion criteria: 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 (e.g. Tanner Stage 2 or above), 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. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within 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. 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 immunodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty*s 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. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests at screening such as AST, ALT, GGT, alkaline phosphatase, or serum bilirubin (must not exceed twice the upper limit value of the normal range for age) 11. Presence of moderate to severe impaired renal function as indicated by clinically significant abnormal creatinine (* 1.5 times ULN) or urea values or abnormal urinary constituents (e.g. albuminuria) at screening. Evidence of urinary obstruction or difficulty in voiding at screening. 12. Use of the following therapies prior to randomization: * Anakinra within 24 hours prior to Baseline visit * Rilonacept within 1 week prior to Baseline visit * Tocilizumab within 3 weeks prior to Baseline visit * Etanercept within 4 w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the proportion of patients who respond to treatment at Day 15 according to the adapted ACR Pediatric 30 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary efficacy endpoints will be analyzed in the order they are presented below: 1. Proportion of patients achieving the adapted ACR Pediatric 30 criteria at Day 29 2. Proportion of patients achieving the adapted ACR Pediatric 50 criteria at Day 29 3. Proportion of patients achieving the adapted ACR Pediatric 50 criteria at Day 15 4. Patient*s pain intensity assessed on a 0-100 mm VAS by Day 29 5. Patient*s pain intensity assessed on a 0-100 mm VAS by Day 15 6. Proportion of patients who have body temperature * 38°C at Day 3 7. Proportion of patients achieving the adapted ACR Pediatric 70 criteria at Day 29 8. Proportion of patients achieving the adapted ACR Pediatric 90 criteria at Day 29 9. Proportion of patients achieving the adapted ACR Pediatric 100 criteria at Day 29 10. Proportion of patients achieving the adapted ACR Pediatric 70 criteria at Day 15 11. Proportion of patients achieving the adapted ACR Pediatric 90 criteria at Day 15 12. Proportion of patients achieving the adapted ACR Pediatric 100 criteria at Day 15 13. Change in HRQoL over time by use of the CHQ 14. Change in disability over time by use of the CHAQ© | — |
Countries
Netherlands
Outcome results
None listed