An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations
- Conditions
- Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis
- Registration Number
- EUCTR2008-008008-42-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 88
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.The following patients are eligible to participate in the open label extension study (CACZ885G2301E1):
•Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 15 days after their initial dose of canakinumab but experience a flare on or after that timepoint
•Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria of 0.5 mg/kg oral prednisone (or equivalent) or were not able to taper their steroids by at least 0.3 mg/kg (please refer to CACZ885G2301 protocol for detailed rules)
•Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped.
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
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 urine pregnancy test
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) or a history of recurrent pericarditis, myocarditis, serositis and/ or biologic features of MAS during the CACZ885G2305 or CACZ885G2301
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; a HIV and hepatitis test should be performed at visit 1 as a follow-up test if one was not done within the past month. The patient may still be dosed prior to receiving the result since this was already confirmed in earlier studies.
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.
•A follow-up TB test should be done at visit 1 if one was not done in the past month (investigator may select best option for the patient: PPD or QuantiFERON) but the result does not need to be available prior to dosing since this was already confirmed in earlier studies.
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.History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia)
11.Uncontrolled hypertension
12.Long QT syndrome or QTc (calculated using Bazett’s formula) > 450 msec for
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To assess the long-term safety, tolerability, and immunogenicity of canakinumab <br>•To assess efficacy at an exploratory level by investigating disease control defined by maintenance of at least an adapted ACR pediatric 30 during the extension part;Secondary Objective: ;Primary end point(s): - Long-term safety, tolerability, and immunogenicity of canakinumab<br>- Disease control by maintenance of at least an adapted ACR pediatric 30 during the extension study
- Secondary Outcome Measures
Name Time Method