Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
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| ClinicalTrials.gov Identifier: NCT02396212 |
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Recruitment Status :
Completed
First Posted : March 24, 2015
Last Update Posted : September 24, 2018
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
This is 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 will support a registration submission of canakinumab in the indication of SJIA in Japan.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Juvenile Idiopathic Arthritis | Biological: Canakinumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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) |
| Actual Study Start Date : | May 7, 2015 |
| Actual Primary Completion Date : | March 7, 2017 |
| Actual Study Completion Date : | August 2, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Juvenile idiopathic arthritis
Drug Information available for:
Canakinumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Canakinumab 4 mg/kg every 4 weeks
All patients will receive canakinumab (ACZ885) as open-label study medication. Patients will be administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed is 300 mg.
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Biological: Canakinumab
Canakinumab 4mg/kg every 4 weeks |
Primary Outcome Measures :
- Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteria [ Time Frame: Week 8 ]To evaluate the efficacy of canakinumab, defined as the proportion of patients who achieved a minimum adapted ACR Pediatric 30 criteria at Week 8
- Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully [ Time Frame: Week 28 ]To evaluate the proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
Secondary Outcome Measures :
- Proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time [ Time Frame: Week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the efficacy (proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria) of canakinumab over time
- Change from baseline in components of the adapted ACR pediatric criteria of canakinumab over time [ Time Frame: Baseline, Day3 (NA for CHAQ valuables), Week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]Change/percent change from baseline will be provided by visit. ACR components: Physician's Global Assessment of disease activity, Parent's or patient's Global Assessment of Subject's overall well-being, Functional ability of CHAQ, Number of joints with active arthritis using the ACR definition, Number of joints with limitation of motion, Standardized CRP. Number of patients having fever will be described by visit.
- Proportion of patients who had flares with canakinumab treatment over time [ Time Frame: Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the proportion of patients who had flares with canakinumab treatment over time
- Proportion of patients who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time [ Time Frame: Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the proportion of patients who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time
- Changes from baseline in CRP levels with canakinumab treatment over time [ Time Frame: Baseline, Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the change in CRP levels with canakinumab treatment over time
- Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully over time [ Time Frame: Week12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully over time
- Corticosteroids dose reduction with canakinumab treatment over time [ Time Frame: Week12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate corticosteroids dose reduction with canakinumab treatment over time
- Number and percentage of patients with adverse events [ Time Frame: Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the safety and tolerability of canakinumab
- Percentage of patients with notable abnormalities in laboratory parameters newly occurred after baseline [ Time Frame: Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the safety and tolerability of canakinumab
- Percentage of patients with notable abnormalities in vital sign newly occurred after baseline [ Time Frame: Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the safety and tolerability of canakinumab
- Serum concentration of canakinumab and total IL-1 beta [ Time Frame: Baseline, Day3, Week2, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate serum concentration (mean, standard deviation) of canakinumab and total IL-1 beta
- Immunogenicity of canakinumab [ Time Frame: Baseline, Week24, 48, 72, 96, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months. ]To evaluate the immunogenicity of canakinumab
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| Ages Eligible for Study: | 2 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Confirmed diagnosis of SJIA as per 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396212
Locations
| Japan | |
| Novartis Investigative Site | |
| Obu-city, Aichi, Japan, 474-8710 | |
| Novartis Investigative Site | |
| Chiba-city, Chiba, Japan, 266-0007 | |
| Novartis Investigative Site | |
| Kanazawa-city, Ishikawa, Japan, 920-8641 | |
| Novartis Investigative Site | |
| Kagoshima city, Kagoshima, Japan, 890 8520 | |
| Novartis Investigative Site | |
| Yokohama-city, Kanagawa, Japan, 232-8555 | |
| Novartis Investigative Site | |
| Yokohama-city, Kanagawa, Japan, 236-0004 | |
| Novartis Investigative Site | |
| Sendai-city, Miyagi, Japan, 989-3126 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02396212 History of Changes |
| Other Study ID Numbers: |
CACZ885G1301 |
| First Posted: | March 24, 2015 Key Record Dates |
| Last Update Posted: | September 24, 2018 |
| Last Verified: | September 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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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) |
Additional relevant MeSH terms:
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |