An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00891046
• Date of registration: 29/04/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. ß-SPECIFIC 3
• Scientific title: An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever
• Date of first enrolment: September 2009
• Target sample size: 270
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00891046
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

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 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

- AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Rash
Serositis Lymphadenopathy Hepatosplenomegaly

- Naïve to canakinumab

Other protocol-defined inclusion criteria may apply

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 inclusion/exclusion criteria may apply



Age minimum: 2 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Canakinumab

Primary Outcome(s)

Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study [Time Frame: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)]

Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Number of Participants With Clinically Significant Local Injection Site Reactions During the Study [Time Frame: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)]

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE [Time Frame: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)]

Secondary Outcome(s)

Change From Baseline in EuroQual 5 -Dimension Health Status Questionnaire (EQ-5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Disability, Overall Well-Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants With Clinical Remission [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants With Minimum Adapted ACR Pediatric = 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Growth Velocity Parameters to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants With Inactive Disease [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Change From Baseline in Health-Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire- Parent Form (CHQ-PF50) to Last Assessment of Study [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen [Time Frame: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier]

Secondary ID(s)

CACZ885G2301E1

EudraCT: 2008-008008-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pediatric Rheumatology International Trials Organization

Results

• Results available: Yes
• Date Posted: 10/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00891046