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

NCT02396212 | Completed Phase 3 Results

• 2 other identifiers: CACZ885G13012018-002355-15
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

Brief Summary

This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.

Conditions

Systemic Juvenile Idiopathic Arthritis

Keywords

ACZ885; canakinumab; Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Japanese patients

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria

  Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week.

  Week 8

• Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully

  To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28

  Week 28

Secondary Outcomes (14)

• Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time

  Weeks 4, 8, 28, 48, 96, 144, end of study (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

  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: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ

  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: CHAQ: Functional Ability Score

  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 Active Arthritis

  Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)

Study Arms (1)

Canakinumab

EXPERIMENTAL

All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.

Biological: Canakinumab

Interventions

Canakinumab BIOLOGICAL

canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.

Also known as: ACZ885

Canakinumab

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Ōbu, Aichi-ken, 474 8710, Japan

Location

Novartis Investigative Site

Chiba, Chiba, 266-0007, Japan

Location

Novartis Investigative Site

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Novartis Investigative Site

Kagoshima, Kagoshima-ken, 890 8520, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232-8555, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0004, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 989-3126, Japan

Location

Related Publications (1)

• Nishimura K, Hara R, Umebayashi H, Takei S, Iwata N, Imagawa T, Shimizu M, Tomiita M, Seko N, Kitawaki T, Yokota S. Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients. Mod Rheumatol. 2021 Jan;31(1):226-234. doi: 10.1080/14397595.2020.1783163. Epub 2020 Jul 29.

  PMID: 32552266 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Bronchiolitis Obliterans Syndrome; Arthralgia; Rheumatoid Arthritis, Systemic Juvenile

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 24, 2015
• Study Start: May 7, 2015
• Primary Completion: March 7, 2017
• Study Completion: August 1, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)