An Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Systemic Juvenile … (NCT07706868) | Clinical Trial Compass
WithdrawnPhase 4
An Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)
Stopped: Business decision
0Started 2025-09-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD).The study consists of up to four weeks screening, to see if a patient is suitable to the study, 48 weeks of treatment with anakinra and 4 weeks safety follow up after last dose of anakinra. In total 60 patients(expected allocation is 30 SJIA and 30 AOSD), male or female patients, 8 months of age or older with a body weight ≥ 10 kg, will be enrolled to the study.
Who can participate
Age range
8 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent form signed by the patient or a legal guardian representative.
. Male or female patients, 8 months of age or older with a body weight ≥ 10 kg.
. Diagnosis of Still's disease.
. Criteria for diagnosis of Still's disease:
. If \< 16 years of age at disease onset, the diagnosis is made according to international league for associations of rheumatology (ILAR) 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ACR30 response at Week 4 with absence of fever attributable to the disease during the 7 days preceding Week 4 visit.
. Participation in another clinical interventional study 30 days prior to enrollment.
. Treatment with an investigational drug within 5 half-lives prior to enrollment.
. Previous or current treatment with anakinra, or any other 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 (Refer to Exclusion Criteria 5). Patients who have discontinued canakinumab because of insufficient effect, refractory disease or toxicities 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, human immunodeficiency virus (HIV) infection, coronavirus disease (Covid-19) infection, hepatitis B or C infection at baseline.
. Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests: