A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)

• Register: EUCTR
• Last refreshed on: 9 December 2013
• Main ID: EUCTR2012-003054-92-CZ
• Date of registration: 18/12/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)
• Scientific title: An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients
• Date of first enrolment: 18/04/2013
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003054-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 6

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Peru, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Informacní služba - klin. hodnocení
• Affiliation: Novartis s.r.o.

• Name: Informacní služba - klin. hodnocení
• Affiliation: Novartis s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
Cohort 1:
1. All patients currently enrolled in study CACZ885G2301E1, including patients who discontinued canakinumab therapy for inactive disease in CACZ885G2301E1 as per physician discretion and who are now currently in a flare and require canakinumab therapy again

Cohort 2:
1. Male and female patients aged = 2 to < 20 years at the time of the screening visit
2. Confirmed diagnosis of SJIA as per ILAR definition 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:
o Evanescent non-fixed erythematous rash,
o Generalized lymph node enlargement,
o Hepatomegaly and/ or splenomegaly,
o Serositis
3. Active systemic disease at the time of baseline visit defined as having 2 or more of the following:
• Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose,
• At least 2 joints with active arthritis (using ACR definition of active joint),
• C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L),
• Rash,
• Serositis,
• Lymphadenopathy,
• Hepatosplenomegaly
4. Patient’s willingness to discontinue anakinra, rilonacept, tocilizumab or other experimental drug under close monitoring
5. Patients who are scheduled to receive an immunization, according to their local vaccination guidelines, with an inactivated vaccine and willing to participate in the assessment schedule for vaccinated patients

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 220
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Cohort 1 and Cohort 2:
1. Active or recurrent bacterial, fungal or viral infection at the time of enrollment
2. 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
3. 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
4. Live vaccinations within 3 months prior to the start of the study

Cohort 2:
The following additional key exclusion criteria apply for Cohort 2.
1. Presence of moderate to severe impaired renal function
2. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests at screening
3. History/evidence of macrophage activation syndrome within the previous 6 months

Other protocol-defined exclusion criteria may apply.


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

Health Condition(s) or Problem(s) studied

Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Lyophilisate for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Long-term safety and tolerability of canakinumab and the retention rate of canakinumab-treated patients will be evaluated by monitoring of serious adverse events and adverse events leading to discontinuation of study drug

Secondary Objective: Part I: - To assess efficacy as a percentage of patients who meet the adapted pediatric ACR, its individual components, and the Juvenile Arthritis Disease Activity Score [JADAS] over time
- To assess efficacy in the percentage of patients who reported failure to anakinra and tocilizumab using the adapted pediatric ACR
- To evaluate the level of systemic corticosteroid tapering achieved
- To assess change in disability over time by use of the cross culturally adapted and validated version of the CHAQ©
Part II: - To assess time to treatment failure
- To assess efficacy as a percentage of patients who meet the adapted pediatric ACR, its individual components, and the Juvenile Arthritis Disease Activity Score [JADAS] over time
- To evaluate the level of canakinumab tapering achieved after randomization to the dose reduction or dose interval prolongation treatment arm
- To assess change in disability over time by use of the cross culturally adapted and validated version of the CHAQ©

Timepoint(s) of evaluation of this end point: Days 1 to 533

Main Objective: Part I: To evaluate the long-term safety and tolerability of canakinumab and to assess the retention rate of canakinumab treated patients

Part II: To assess the long-term safety and tolerability of canakinumab

Secondary Outcome(s)

Secondary end point(s): 1.The percentage of patients who meet the adapted pediatric ACR, its individual components, and the Juvenile Arthritis Disease Activity Score [JADAS] over time
2. The level of systemic corticosteroid tapering achieved in Part I
3. The level of canakinumab tapering achieved after randomization to the dose reduction arm or dose interval prolongation treatment arm in Part II
4. The time to treatment failure in Part II

Timepoint(s) of evaluation of this end point: 1. Days 1 to 533
2. Day 1 to start of Part II
3. From start of Part II to Day 533
4. From start of Part II to Day 533

Secondary ID(s)

CACZ885G2402

2012-003054-92-AT

Source(s) of Monetary Support

Novartis Pharma Services AG