Still's Disease, Juvenile OnsetPhase 3NCT05814159
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
A Phase 3 study testing Anakinra in people with Still's Disease, Juvenile Onset and Still's Disease, Adult-Onset, run by Swedish Orphan Biovitrum at 8 sites in Japan.
Trial 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]). Read more about this study
- Who is it for?
- Ages 8 months and older
- Conditions the study is for
- Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 8 sitesJapan
- Study dates
- 24 Aug 2022to 24 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients, 8 months of age or older with a body weight ≥ 10 kg
- Diagnosis of Still's disease
- 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.
Who cannot join
- Previous or current treatment with anakinra, or any other Interleukin-1 (IL-1) inhibitor except for canakinumab. Previous treatment with canakinumab is allowed if canakinumab was discontinued for reasons other than lack of efficacy and after a washout period of minimum 130 days. Patients who have discontinued canakinumab because of insufficient effect or refractory disease are not allowed to be enrolled in the study.
- Use of the following therapies prior to enrollment.
- Narcotic analgesics within 24 hours prior to enrollment.
- Diaminodiphenyl sulfone within 1 week prior to enrollment or etanercept within 2 weeks prior to enrollment.
- Intraarticular, intramuscular, or intravenous administration of glucocorticoids within 72h(3 days) prior to enrollment, 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.
Show all 19Show fewer
- Thalidomide within 72h(3 days) prior to enrollment, cyclosporine within 5 weeks prior to enrollment, mycophenolate mofetil within 1 week prior to enrollment, 6-mercaptopurine within 48h(2 days) prior to enrollment, azathioprine within 72h(3 days) prior to enrollment, cyclophosphamide within 96h(4 days) prior to enrollment, chlorambucil (not approved inJapan) within 48h(2 days) prior to enrollment, 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 13 weeks prior to enrollment.
- Canakinumab within 130 days 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.
- History or diagnosis of MAS within the last 4 weeks prior to enrollment.
- After completion of the study Core Phase, patients who consent and are eligible to continue anakinra treatment, can enter the extension phase .
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Tokyo Medical And Dental University Hospital
Bunkyō-Ku, Tokyo
Fukushima Medical University Hospital
Fukushima, Fukushima
Gifu University Hospital
Gifu
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo
Kobe University Hospital
Kobe, Hyōgo
Shinshu University
Matsumoto, Nagano
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo
Yokohama City University Hospital (Hematology and Clinical Immunology)
Yokohama, Kanagawa
About this study
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)
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]).
Read the detailed description
The study consists of two phases:
- Core phase comprising 2 weeks double blind placebo-controlled treatment, 52 weeks open label treatment and 4 weeks safety follow up (only for patients not entering the extension phase).
At the Week 54 visit, patients who consent and are eligible to continue anakinra treatment, will enter the extension phase and continue open label anakinra treatment.
- Extension phase comprising up to 26 weeks open label treatment and 4 weeks safety follow up.
The primary endpoint will be evaluated at Week 2 visit.
- Being tested
- Anakinra, Placebo
- Medical subject headings
- Arthritis, Juvenile, Still's Disease, Adult-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
sub cutaneous daily injection
PlaceboDrug
sub cutaneous daily injection
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | 100 mg/day or 2 mg/kg/day of subcutaneous anakinra for those with a body weight ≥50 kg or <50 kg, respectively. Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Corresponding volume to 100 mg/day or 2 mg/kg/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 2
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
Measured: Week 2
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
Measured: Week 2
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
Measured: Week 2
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
Measured: Week 2
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
Measured: Week 2
Secondary outcomes (56)
Change in CRP.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Measured: Week 2
Change in ferritin.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Measured: Week 2
Change in haemoglobin.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Measured: Week 2
Change in platelets count.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Measured: Week 2
Change in white blood cells count.
To demonstrate the efficacy of anakinra compared to placebo in reducing inflammation in Still's disease.
Measured: Week 2
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
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.
Measured: Week 1
Change in swelling joints count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in tender joints count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in CRP.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in ferritin.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in haemoglobin.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in platelets count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
Change in white blood cells count.
To demonstrate early onset of efficacy of anakinra compared to placebo in Still's disease.
Measured: Week 1
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.
Measured: Week 2
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.
Measured: Week 2
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.
Measured: Week 2
Absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Absence of rash during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
ACR30 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
ACR50 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
ACR70 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
ACR90 response with absence of fever during the 7 days preceding the visit.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in physician global assessment of disease activity (VAS).
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in patient/parent global assessment of overall well-being (VAS).
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in patient/parent global assessment of disease related pain (VAS).
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in swelling joints count.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in tender joints count.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in CRP.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in ferritin.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in haemoglobin.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in platelets count.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
Change in white blood cells count.
To evaluate efficacy of anakinra in Still's disease.
Measured: Week 4 to Week 54
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.
Measured: Week 8 to Week 54
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.
Measured: Week 4 to Week 54
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.
Measured: Week 4 to Week 54
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.
Measured: Week 4 to Week 54
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.
Measured: Week 2 to Week 54
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.
Measured: Day 1 to Week 54
Time of initiation of glucocorticoids tapering.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Measured: Week 2 to Week 54
Percentage decrease of glucocorticoids dose for patients tapering their glucocorticoids dose.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Measured: Week 2 to Week 54
Discontinuation of glucocorticoids.
To evaluate glucocorticoids tapering in anakinra treated patients with Still's disease.
Measured: Week 2 to Week 54
- Occurrence of adverse events (AEs) (serious adverse events [SAEs] and non-SAEs).
To evaluate the safety of anakinra in patients with Still ́s disease.
Measured: Baseline to Week 58
Occurrence of deaths
To evaluate the safety of anakinra in patients with Still ́s disease.
Measured: Baseline to Week 58
Occurrence of AEs leading to study drug discontinuation at all study visits.
To evaluate the safety of anakinra in patients with Still ́s disease.
Measured: Baseline to Week 58
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.
Measured: Baseline to Week 58
Occurrence of laboratory safety assessments changes over time.
To evaluate the safety of anakinra in patients with Still ́s disease.
Measured: Baseline to Week 58
Occurrence of abnormal laboratory values.
To evaluate the safety of anakinra in patients with Still ́s disease.
Measured: Baseline to Week 58
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
Measured: Baseline, Weeks 2, 4, 12, 34, 54 and 58
To evaluate the pharmacokinetic of anakinra in patients with Still's disease
Anakinra serum concentrations
Measured: Baseline, Weeks 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start24 Aug 2022
- Primary completion10 Dec 2025 (estimated)
- Study completion24 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Still's Disease, Juvenile OnsetStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Responsible party
- Sponsor
- Investigators
- Masaaki Mori, MD, Principal investigator, St. Marianna University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814159
- Sponsor's protocol ID
- Sobi.ANAKIN-303
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05814159
- Acronym / sponsor ID
- Sobi.ANAKIN-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- CMIC Co, Ltd. Japan
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 24 Jun 2026 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 two phases:
- Core phase comprising 2 weeks double blind placebo-controlled treatment, 52 weeks open label treatment and 4 weeks safety follow up (only for patients not entering the extension phase).
At the Week 54 visit, patients who consent and are eligible to continue anakinra treatment, will enter the extension phase and continue open label anakinra treatment.
- Extension phase comprising up to 26 weeks open label treatment and 4 weeks safety follow up.
The primary endpoint will be evaluated at Week 2 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra100 mg/day or 2 mg/kg/day of subcutaneous anakinra for those with a body weight ≥50 kg or <50 kg, respectively. |
| Placebo | Placebo comparator | Drug: PlaceboCorresponding volume to 100 mg/day or 2 mg/kg/day |
Who may qualify
- Ages
- 8 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients, 8 months of age or older with a body weight ≥ 10 kg
- Diagnosis of Still's disease
- 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.
Key exclusion criteria (19 listed)
- Previous or current treatment with anakinra, or any other Interleukin-1 (IL-1) inhibitor except for canakinumab. Previous treatment with canakinumab is allowed if canakinumab was discontinued for reasons other than lack of efficacy and after a washout period of minimum 130 days. Patients who have discontinued canakinumab because of insufficient effect or refractory disease are not allowed to be enrolled in the study.
- Use of the following therapies 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraAlso: Kineretsub cutaneous daily injection | Drug | Anakinra |
| Placebosub cutaneous daily injection | Drug | Placebo |
Primary outcome
An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]).
Time frame: Week 2
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).
Time frame: Week 2
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.
Time frame: Week 2
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.
Time frame: Week 2
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).
Time frame: Week 2
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).
Time frame: Week 2
ACR30 response with absence of fever attributable to the disease during the 7 days
56 secondary outcomes
Change in CRP.
Time frame: Week 2
Change in ferritin.
Time frame: Week 2
Change in haemoglobin.
Time frame: Week 2
Change in platelets count.
Time frame: Week 2
Change in white blood cells count.
Time frame: Week 2
Absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Time frame: Week 1
Absence of rash during the 24 hours preceding the evaluation visit at Week 1.
Time frame: Week 1
ACR30 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Time frame: Week 1
ACR50 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Time frame: Week 1
ACR70 response with absence of fever during the 24 hours preceding the evaluation visit at Week 1.
Time frame: Week 1
Change in physician global assessment of disease activity, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Time frame: Week 1
Change in patient/parent global assessment of overall well-being, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Time frame: Week 1
Change in patient/parent global assessment of disease related pain, measured on a VAS from no pain (0 mm) to very severe (100 mm).
Time frame: Week 1
Change in swelling joints count.
Time frame: Week 1
Change in tender joints count.
Time frame: Week 1
Change in CRP.
Time frame: Week 1
Change in ferritin.
Time frame: Week 1
Change in haemoglobin.
Time frame: Week 1
Change in platelets count.
Time frame: Week 1
Change in white blood cells count.
Time frame: Week 1
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y Proxy (4-7 years).
Time frame: Week 2
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-Y (8-15 years).
Time frame: Week 2
Change in the number/proportion of patients reporting problems by dimension of EQ-5D-3L (≥ 16 years).
Time frame: Week 2
Absence of fever during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
Absence of rash during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
ACR30 response with absence of fever during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
ACR50 response with absence of fever during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
ACR70 response with absence of fever during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
ACR90 response with absence of fever during the 7 days preceding the visit.
Time frame: Week 4 to Week 54
Change in physician global assessment of disease activity (VAS).
Time frame: Week 4 to Week 54
Change in patient/parent global assessment of overall well-being (VAS).
Time frame: Week 4 to Week 54
Change in patient/parent global assessment of disease related pain (VAS).
Time frame: Week 4 to Week 54
Change in swelling joints count.
Time frame: Week 4 to Week 54
Change in tender joints count.
Time frame: Week 4 to Week 54
Change in CRP.
Time frame: Week 4 to Week 54
Change in ferritin.
Time frame: Week 4 to Week 54
Change in haemoglobin.
Time frame: Week 4 to Week 54
Change in platelets count.
Time frame: Week 4 to Week 54
Change in white blood cells count.
Time frame: Week 4 to Week 54
Occurrence of inactive disease.
Time frame: Week 8 to Week 54
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaaki Mori, MD principal investigator
St. Marianna University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anakinra in people with Still's Disease, Juvenile Onset and Still's Disease, Adult-Onset, run by Swedish Orphan Biovitrum at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An improvement of ≥ 30% from baseline in physician global assessment of disease activity (visual analogue scale [VAS]). (time frame: Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.