A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA

• Register: EUCTR
• Last refreshed on: 25 September 2012
• Main ID: EUCTR2008-008008-42-Outside-EU/EEA
• Date of registration: 09/03/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis PharmaServices AG
• Public title: A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA
• Scientific title: An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1
• Target sample size: 200
• Recruitment status: NA
• 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: 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

Countries of recruitment

Argentina, Brazil, Canada, Israel, Peru, Russian Federation, South Africa, Switzerland, Turkey, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
•Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or 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 , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in
Part II.
•Treatment- naïve patients need to meet the following criteria:
? Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age
? Male and female patients aged = 2 to < 20 years of age
? Active disease at the time of enrollment defined as follows: At least 2 joints with active arthritis AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
? Naïve to canakinumab

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 190
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• History of allergy or hypersensitivity to study drug
• With active or recurrent bacterial, fungal or viral infections at time of enrollment

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: 10028395 - Musculoskeletal and connective tissue disorders

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

Intervention(s)

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: 25-

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-

Primary Outcome(s)

Primary end point(s): 1. Assess the long-term safety, tolerability and immunogenicity of canakinumab.
2. Maintenance of at least an adapted ACR pediatric 30.
3. Assess efficacy of canakinumab treatment based on adapted ACR pediatric 30 criteria in patients who report previous anakinra, tocilizumab or other biologic treatment

Secondary Objective:

Timepoint(s) of evaluation of this end point: Days 1 to 728

Main Objective: This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued
efficacy and safety until discontinuation or until OctoberDecember, 2012. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Days 1 to 728

Secondary end point(s): 1. The number of patients that were able to taper steroid as per protocol.
2. The number of patients who reached steroid free regimen.
3. The number of patients who were able to reduce the canakinumab dose to 2 mg/kg/4 week
4.The percentage of patients who will meet the definition of inactive disease on medication and possible clinical remission on medication

Secondary ID(s)

2008-008008-42-FR

CACZ885G2301E1

Source(s) of Monetary Support

Novartis Pharma Services AG