An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND

• Register: EUCTR
• Last refreshed on: 28 September 2015
• Main ID: EUCTR2008-008008-42-IT
• Date of registration: 05/08/2009
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND
• Scientific title: An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND
• Date of first enrolment: 22/06/2009
• Target sample size: 88
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008008-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: open If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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. 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

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 urine pregnancy test 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 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 studies 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. Section 7.2.1 describes further details for positive results. 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...PLS SEE PROTOCOL


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0 Level: LLT Classification code 10059177 Term: Juvenile arthritis

Intervention(s)

Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: canakinumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Primary end point(s): -Long term safety, tolerability and immunogenicity of canakinumab. -Disease control by maintenance of at least an adapted ACR pediatyric 30 during the extension study

Secondary Objective: The objectives of the extension trial are: To assess the long-term safety, tolerability and immunogenicity of Canakinumab 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 phase

Main Objective: The objectives of the extension trial are: To assess the long-term safety, tolerability and immunogenicity of Canakinumab 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 phase

Secondary ID(s)

CACZ885G2301E1

2008-008008-42-FR