Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02396212
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
• Scientific title: An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
• Date of first enrolment: May 7, 2015
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02396212
• 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

Japan

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria

- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR)
definition (Petty, et al. 2004) that must have occurred at least 3 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: Rash
due to SJIA, lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis

- Active disease at the time of baseline defined as follows:

- At least 2 joints with active arthritis

- Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day
during the screening epoch and within 1 week before first canakinumab dose

- C-Reactive Protein (CRP) > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))

- Negative TB screen (Chest X-ray and T-SPOT test)

Exclusion Criteria:

- 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. Patients with resolved/previous
hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or
anti-HBc antibody).

- 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.

- With neutropenia (absolute neutrophil count < 1500/mm3) at screening.



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

Health Condition(s) or Problem(s) studied

Systemic Juvenile Idiopathic Arthritis

Intervention(s)

Biological: Canakinumab

Primary Outcome(s)

Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully [Time Frame: Week 28]

Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria [Time Frame: Week 8]

Secondary Outcome(s)

Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time [Time Frame: Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Serum Concentration of Canakinumab [Time Frame: Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164)]

Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time [Time Frame: Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164)]

Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time [Time Frame: Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164)]

Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time [Time Frame: Weeks 28, 48, 96, 144, EOS (up to Week 164)]

Pharmacodynamics (PD) Assessment: Total IL-1 Beta [Time Frame: Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164)]

Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164]

Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion [Time Frame: Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)]

Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time [Time Frame: > Day3, to <= Week 124]

Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time [Time Frame: Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164)]

Secondary ID(s)

CACZ885G1301

2018-002355-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02396212