Back to resultsA Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Primary Purpose
Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Still's Disease, Juvenile Onset
Eligibility Criteria
Inclusion Criteria: Male and female patients, 8 months of age or older with a body weight ≥ 10 kg Diagnosis of Still's disease within 15 months prior to enrollment. If < 16 years of age at disease onset, the diagnosis is madeaccording to adapted ILAR criteria i.e., CARRA criteria for SJIA. If ≥ 16 years of age at disease onset, the diagnosis is made according to Yamaguchi criteria for AOSD. Active disease confirmed by the following three signs and symptoms. a. Active arthritis in ≥ 1 joint. b. CRP > 30 mg/L. c. At least one fever episode (≥ 38.0 degree Celsius) attributable to the disease within one week before enrollment. The result of tuberculosis test within 8 weeks prior to enrollment is negative. Exclusion Criteria: Previous or current treatment with anakinra, canakinumab,or any other Interleukin-1 (IL-1) inhibitor. Use of the following therapies prior to enrollment. Narcotic analgesics within 24 hours prior to enrollment. Diaminodiphenyl sulfone or etanercept within 3 weeks prior to enrollment. Intraarticular, intramuscular, or intravenous administration of glucocorticoids, or intravenous immunoglobulin within 4 weeks prior to enrollment. Intravenous immunoglobulins with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment. Thalidomide, cyclosporine, mycophenolate mofetil, 6-mercaptopurine, azathioprine, cyclophosphamide, chlorambucil (not approved inJapan), or any other immunosuppressants within 12 weeks prior to enrollment. Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medications within 4 half-lives prior to enrollment. Rituximab within 26 weeks prior to enrollment. Live vaccines within 4 weeks prior to enrollment. Known presence or suspicion of active, chronic, or recurrent bacterial, fungal, or viral infections, including but not limited to tuberculosis, HIV infection, Covid-19 infection, or hepatitis B or C infection at baseline. Patients with acute or chronic HBV. Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests. Presence of severe chronic kidney disease (CKD) grades 4 and 5. Presence of neutropenia (absolute neutrophil count [ANC] < 1.5 x 10^9/L). Presence of thrombocytopenia (platelets count < 100 x 10^9/L). Presence or suspicion of MAS at baseline. A diagnosis of MAS within the last 8 weeks prior to enrollment.
Sites / Locations
- Chiba Children's HospitalRecruiting
- Kurume University HospitalRecruiting
- Fukushima Medical University HospitalRecruiting
- Sapporo Medical University HospitalRecruiting
- Kobe University HospitalRecruiting
- St. Marianna University HospitalRecruiting
- Yokohama City University Hospital (Hematology and Clinical Immunology)Recruiting
- Yokohama City University Hospital (pediatrics)Recruiting
- Shinshu UniversityRecruiting
- Nagasaki University HospitalRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Saitama Medical University HospitalRecruiting
- Saitama Prefectural Children's Medical CenterRecruiting
- Shimane University HospitalRecruiting
- Hamamatsu University HospitalRecruiting
- Tokyo Medical And Dental University HospitalRecruiting
- Toho University Omori Medical CenterRecruiting
- Tokyo Women's Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anakinra
Placebo
Arm Description
100 mg/day or 2 mg/kg/day of subcutaneous anakinra for those with a body weight ≥50 kg or <50 kg, respectively.
Corresponding volume to 100 mg/day or 2 mg/kg/day
Outcomes
Primary Outcome Measures
An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).
ACR30 response with absence of fever attributable to the disease during the 7 days
An improvement of ≥ 30% from baseline in patient/parent global assessment of overall well-being (VAS).
ACR30 response with absence of fever attributable to the disease during the 7 days
An improvement of ≥ 30% from baseline in number of joints with active arthritis.
ACR30 response with absence of fever attributable to the disease during the 7 days
An improvement of ≥ 30% from baseline in number of joints with limitation of motion.
ACR30 response with absence of fever attributable to the disease during the 7 days
An improvement of ≥ 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).
ACR30 response with absence of fever attributable to the disease during the 7 days
An improvement of ≥ 30% from baseline in C-reactive protein (CRP) (mg/L).
ACR30 response with absence of fever attributable to the disease during the 7 days
Secondary Outcome Measures
Change in CRP.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Change in ferritin.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Change in haemoglobin.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Change in platelets count.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Change in white blood cells count.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Absence of fever during the 24 hours preceding the evaluation visit at Week 1.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Absence of rash during the 24 hours preceding the evaluation visit at Week 1.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
ACR30 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
ACR50 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
ACR70 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in physician global assessment of disease activity, measured on a VAS from no pain (0 mm) to very severe (100 mm).
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in patient/parent global assessment of overall well-being, measured on a VAS from no pain (0 mm) to very severe (100 mm).
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in patient/parent global assessment of disease related pain, measured on a VAS from no pain (0 mm) to very severe (100 mm).
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in swelling joints count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in tender joints count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in CRP.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in ferritin.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in haemoglobin.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in platelets count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in white blood cells count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y Proxy (4-7 years).
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y (8-15 years).
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-3L (≥ 16 years).
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Absence of rash during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
ACR30 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
ACR50 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
ACR70 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
ACR90 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Change in physician global assessment of disease activity (VAS).
To evaluate efficacy of anakinra in Still's disease.
Change in patient/parent global assessment of overall well-being (VAS).
To evaluate efficacy of anakinra in Still's disease.
Change in patient/parent global assessment of disease related pain (VAS).
To evaluate efficacy of anakinra in Still's disease.
Change in swelling joints count.
To evaluate efficacy of anakinra in Still's disease.
Change in tender joints count.
To evaluate efficacy of anakinra in Still's disease.
Change in CRP.
To evaluate efficacy of anakinra in Still's disease.
Change in ferritin.
To evaluate efficacy of anakinra in Still's disease.
Change in haemoglobin.
To evaluate efficacy of anakinra in Still's disease.
Change in platelets count.
To evaluate efficacy of anakinra in Still's disease.
Change in white blood cells count.
To evaluate efficacy of anakinra in Still's disease.
Occurrence of inactive disease.
Proportion of patients who reach inactive disease.Inactive disease is defined as no joints with active arthritis, no fever, no rash, serositis, no hepatosplenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS, and a documented morning stiffness ≤15 min.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y Proxy (4-7 years).
To evaluate the health status in anakinra treated patients with Still's disease.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y (8-15 years).
To evaluate the health status in anakinra treated patients with Still's disease.
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-3L(≥ 16 years).
To evaluate the health status in anakinra treated patients with Still's disease.
ACR30 response with absence of fever during the 7 days preceding the study visits over time.
To evaluate sustained efficacy of anakinra in patients responding to study drug.
To evaluate the occurrence of study drug discontinuation in anakinra treated patients with Still's disease.
Time to study drug discontinuation due to lack of efficacy or progressive disease.
Time to study drug discontinuation due to any reason.
Number of patients discontinuing study treatment.
Time of initiation of glucocorticoids tapering.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Percentage decrease of glucocorticoids dose for patients tapering their glucocorticoids dose.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Discontinuation of glucocorticoids.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
- Occurrence of adverse events (AEs) (serious adverse events [SAEs] and non-SAEs).
To evaluate the safety of anakinra in patients with Still ́s disease.
Occurrence of deaths
To evaluate the safety of anakinra in patients with Still ́s disease.
Occurrence of AEs leading to study drug discontinuation at all study visits.
To evaluate the safety of anakinra in patients with Still ́s disease.
Occurrence of vital signs changes from baseline, including blood pressure, heart rate, and body weight at all study visits up to Week 58 visit. Changes of height in patients younger than 19 years old.
To evaluate the safety of anakinra in patients with Still ́s disease.
Occurrence of laboratory safety assessments changes over time.
To evaluate the safety of anakinra in patients with Still ́s disease.
Occurrence of abnormal laboratory values.
To evaluate the safety of anakinra in patients with Still ́s disease.
To evaluate immunogenicity of anakinra in patients with Still's disease.
Occurrence of ADAs, NAbs, cross-reactivity, and titer levels of ADAs and NAbs
Occurrence and titer levels of ADAs in relation to AEs
Occurrence and titer levels of ADAs, NAbs cross-reactivityin relation to ACR30 response and CRP levels
To evaluate the pharmacokinetic of anakinra in patients with Still's disease
Anakinra serum concentrations
Full Information
NCT ID
NCT05814159
First Posted
November 22, 2022
Last Updated
April 3, 2023
Sponsor
Swedish Orphan Biovitrum
Collaborators
CMIC Co, Ltd. Japan
1. Study Identification
Unique Protocol Identification Number
NCT05814159
Brief Title
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of Subcutaneous Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
Collaborators
CMIC Co, Ltd. Japan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis [SJIA] and Adult-onset Still's disease [AOSD]).
Detailed Description
The study consists of a 2-Week, randomized, double-blind, placebo-controlled period, followed by a 52-Week open-label phase treatment with anakinra. After the last dose of anakinra at Week 54, the safety will be evaluated at a Safety Follow-up visit i.e., at Week 58.
The primary endpoint will be evaluated at Week 2 visit. Patients will be randomly assigned to either anakinra or placebo for a period of 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anakinra
Arm Type
Experimental
Arm Description
100 mg/day or 2 mg/kg/day of subcutaneous anakinra for those with a body weight ≥50 kg or <50 kg, respectively.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Corresponding volume to 100 mg/day or 2 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
sub cutaneous daily injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sub cutaneous daily injection
Primary Outcome Measure Information:
Title
An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Title
An improvement of ≥ 30% from baseline in patient/parent global assessment of overall well-being (VAS).
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Title
An improvement of ≥ 30% from baseline in number of joints with active arthritis.
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Title
An improvement of ≥ 30% from baseline in number of joints with limitation of motion.
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Title
An improvement of ≥ 30% from baseline in assessment of physical function: Child health assessment questionnaire (CHAQ)/Stanford health assessment questionnaire (SHAQ).
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Title
An improvement of ≥ 30% from baseline in C-reactive protein (CRP) (mg/L).
Description
ACR30 response with absence of fever attributable to the disease during the 7 days
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
Change in CRP.
Description
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Time Frame
Week 2
Title
Change in ferritin.
Description
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Time Frame
Week 2
Title
Change in haemoglobin.
Description
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Time Frame
Week 2
Title
Change in platelets count.
Description
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Time Frame
Week 2
Title
Change in white blood cells count.
Description
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Time Frame
Week 2
Title
Absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Absence of rash during the 24 hours preceding the evaluation visit at Week 1.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
ACR30 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
ACR50 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
ACR70 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in physician global assessment of disease activity, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in patient/parent global assessment of overall well-being, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in patient/parent global assessment of disease related pain, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in swelling joints count.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in tender joints count.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in CRP.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in ferritin.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in haemoglobin.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in platelets count.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in white blood cells count.
Description
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Time Frame
Week 1
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y Proxy (4-7 years).
Description
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Time Frame
Week 2
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y (8-15 years).
Description
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Time Frame
Week 2
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-3L (≥ 16 years).
Description
To evaluate and compare the health status between anakinra treated patients and patients treated with placebo.
Time Frame
Week 2
Title
Absence of fever during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Absence of rash during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
ACR30 response with absence of fever during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
ACR50 response with absence of fever during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
ACR70 response with absence of fever during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
ACR90 response with absence of fever during the 7 days preceding the visit.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in physician global assessment of disease activity (VAS).
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in patient/parent global assessment of overall well-being (VAS).
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in patient/parent global assessment of disease related pain (VAS).
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in swelling joints count.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in tender joints count.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in CRP.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in ferritin.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in haemoglobin.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in platelets count.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in white blood cells count.
Description
To evaluate efficacy of anakinra in Still's disease.
Time Frame
Week 4 to Week 54
Title
Occurrence of inactive disease.
Description
Proportion of patients who reach inactive disease.Inactive disease is defined as no joints with active arthritis, no fever, no rash, serositis, no hepatosplenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS, and a documented morning stiffness ≤15 min.
Time Frame
Week 8 to Week 54
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y Proxy (4-7 years).
Description
To evaluate the health status in anakinra treated patients with Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y (8-15 years).
Description
To evaluate the health status in anakinra treated patients with Still's disease.
Time Frame
Week 4 to Week 54
Title
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-3L(≥ 16 years).
Description
To evaluate the health status in anakinra treated patients with Still's disease.
Time Frame
Week 4 to Week 54
Title
ACR30 response with absence of fever during the 7 days preceding the study visits over time.
Description
To evaluate sustained efficacy of anakinra in patients responding to study drug.
Time Frame
Week 2 to Week 54
Title
To evaluate the occurrence of study drug discontinuation in anakinra treated patients with Still's disease.
Description
Time to study drug discontinuation due to lack of efficacy or progressive disease.
Time to study drug discontinuation due to any reason.
Number of patients discontinuing study treatment.
Time Frame
Day 1 to Week 54
Title
Time of initiation of glucocorticoids tapering.
Description
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Time Frame
Week 2 to Week 54
Title
Percentage decrease of glucocorticoids dose for patients tapering their glucocorticoids dose.
Description
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Time Frame
Week 2 to Week 54
Title
Discontinuation of glucocorticoids.
Description
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Time Frame
Week 2 to Week 54
Title
- Occurrence of adverse events (AEs) (serious adverse events [SAEs] and non-SAEs).
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
Occurrence of deaths
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
Occurrence of AEs leading to study drug discontinuation at all study visits.
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
Occurrence of vital signs changes from baseline, including blood pressure, heart rate, and body weight at all study visits up to Week 58 visit. Changes of height in patients younger than 19 years old.
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
Occurrence of laboratory safety assessments changes over time.
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
Occurrence of abnormal laboratory values.
Description
To evaluate the safety of anakinra in patients with Still ́s disease.
Time Frame
Baseline to Week 58
Title
To evaluate immunogenicity of anakinra in patients with Still's disease.
Description
Occurrence of ADAs, NAbs, cross-reactivity, and titer levels of ADAs and NAbs
Occurrence and titer levels of ADAs in relation to AEs
Occurrence and titer levels of ADAs, NAbs cross-reactivityin relation to ACR30 response and CRP levels
Time Frame
Baseline, Weeks 2, 4, 12, 34, 54 and 58
Title
To evaluate the pharmacokinetic of anakinra in patients with Still's disease
Description
Anakinra serum concentrations
Time Frame
Baseline, Weeks 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients, 8 months of age or older with a body weight ≥ 10 kg
Diagnosis of Still's disease within 15 months prior to enrollment.
If < 16 years of age at disease onset, the diagnosis is madeaccording to adapted ILAR criteria i.e., CARRA criteria for SJIA. If ≥ 16 years of age at disease onset, the diagnosis is made according to Yamaguchi criteria for AOSD.
Active disease confirmed by the following three signs and symptoms. a. Active arthritis in ≥ 1 joint. b. CRP > 30 mg/L. c. At least one fever episode (≥ 38.0 degree Celsius) attributable to the disease within one week before enrollment.
The result of tuberculosis test within 8 weeks prior to enrollment is negative.
Exclusion Criteria:
Previous or current treatment with anakinra, canakinumab,or any other Interleukin-1 (IL-1) inhibitor.
Use of the following therapies prior to enrollment.
Narcotic analgesics within 24 hours prior to enrollment.
Diaminodiphenyl sulfone or etanercept within 3 weeks prior to enrollment.
Intraarticular, intramuscular, or intravenous administration of glucocorticoids, or intravenous immunoglobulin within 4 weeks prior to enrollment.
Intravenous immunoglobulins with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment.
Thalidomide, cyclosporine, mycophenolate mofetil, 6-mercaptopurine, azathioprine, cyclophosphamide, chlorambucil (not approved inJapan), or any other immunosuppressants within 12 weeks prior to enrollment.
Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medications within 4 half-lives prior to enrollment.
Rituximab within 26 weeks prior to enrollment.
Live vaccines within 4 weeks prior to enrollment.
Known presence or suspicion of active, chronic, or recurrent bacterial, fungal, or viral infections, including but not limited to tuberculosis, HIV infection, Covid-19 infection, or hepatitis B or C infection at baseline. Patients with acute or chronic HBV.
Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests.
Presence of severe chronic kidney disease (CKD) grades 4 and 5.
Presence of neutropenia (absolute neutrophil count [ANC] < 1.5 x 10^9/L).
Presence of thrombocytopenia (platelets count < 100 x 10^9/L).
Presence or suspicion of MAS at baseline.
A diagnosis of MAS within the last 8 weeks prior to enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Paillé, MD
Phone
+41-615087213
Email
sabrina.paille@sobi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuichiro Nakayama
Email
yuichiro.nakayama@sobi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Mori, MD
Organizational Affiliation
St. Marianna University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiba Children's Hospital
City
Chiba-shi
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minako Tomiita, MD
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuta Nishikomri, MD
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Migita, MD
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Takahashi, MD
Facility Name
Kobe University Hospital
City
Kobe city
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Saegusa, MD
Facility Name
St. Marianna University Hospital
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuko Yamazaki, MD
Facility Name
Yokohama City University Hospital (Hematology and Clinical Immunology)
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohei Kirino, MD
Facility Name
Yokohama City University Hospital (pediatrics)
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuichi Ito, MD
Facility Name
Shinshu University
City
Matsumoto
State/Province
Nagano
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiro shimoijma, MD
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Kawakami, MD
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuka Ozeki, MD
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihide Mimura, MD
Facility Name
Saitama Prefectural Children's Medical Center
City
Saitama-shi
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Sato, MD
Facility Name
Shimane University Hospital
City
Izumo-shi
State/Province
Shimane
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Kondo, MD
Facility Name
Hamamatsu University Hospital
City
Hamamatsu city
State/Province
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noriyoshi Ogawa, MD
Facility Name
Tokyo Medical And Dental University Hospital
City
Bunkyō-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Shimizu, MD
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiro Nanki, MD
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takako Miyamae, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
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