An Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)

NCT07706868 | Withdrawn Phase 4

• 1 other identifier: Sobi.ANAKIN-304
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Systemic Juvenile Idiopathic Arthritis (sJIA); Adult Onset Still's Disease (AOSD)

Outcome Measures

Primary Outcomes (1)

• ACR30 response at Week 4 with absence of fever attributable to the disease during the 7 days preceding Week 4 visit.

  Definition of American College of Rheumatology (ACR) 30 response in SJIA and AOSD patients: An improvement of ≥ 30% from baseline to Week 4 visit, in at least 3 of any 6 variables of the ACR core set listed below, with no more than 1 variable worsening by \> 30%. 1. Physician global assessment of disease activity (visual analogue scale \[VAS\]). 2. Patient/parent global assessment of overall well-being (VAS). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function (Child health assessment questionnaire \[CHAQ\]/ Stanford health assessment questionnaire \[SHAQ\]). 6. CRP (mg/L). Definition of fever: Body temperature ≥ 38.0 °C attributable to the disease. Definition of active arthritis: Joint with swelling. In absence of swelling, limitation of range of motion accompanied by either pain on motion or tenderness not due to deformity.

  Up to 48 weeks.

Secondary Outcomes (24)

• Absence of fever during the 7 days preceding week 4.

  Up to week 48.

• Absence of rash during the 7 days preceding Week 4.

  Up to week 48.

• ACR50, ACR70, and ACR90 response with absence of fever during the 7 days preceding Week 4.

  Up to week 48.

• Absence of fever during the 7 days preceding each visit.

  Up to week 48.

• Absence of rash during the 7 days preceding each visit.

  Up to week 48.

Study Arms (1)

Anakinra

EXPERIMENTAL

Anakinra, once daily s.c. injection, starting dose of 100 mg/day for patients with body weight ≥ 50 kg and 1-2 mg/kg/day for patients with body weight \< 50 kg. Pediatric and adult patients weighing ≥ 50kg will receive 100 mg anakinra per day by subcutaneous injection. Pediatric and adult patients weighing \< 50 kg should be dosed by body weight with a starting dose of anakinra of 1 to 2 mg/kg/day (with a max of 100 mg/day). If patients receiving 1 mg/kg/d are not responding at Week 1, the dose will be escalated to 2 mg/kg/day. If at the appreciation of the investigator, a patient \< 16 years old with a body weight below 50 kg, is not responding sufficiently to anakinra treatment at Week 4 visit, the dose will be adjusted according to actual body weight (rounded to the nearest kg) and will be increased up to 4 mg/kg/day with a max of 200 mg/day or the continuation of anakinra will be considered by the investigator.

Drug: Anakinra (Kineret®)

Interventions

Anakinra (Kineret®) DRUG

Subcutaneous injections once daily for 48 weeks

Anakinra

Eligibility Criteria

• Age: 8 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Active arthritis in ≥ 1 joint.
• CRP \> 30 mg/L.
• At least one fever episode attributable to the disease within one week before enrollment.
• Definition of fever: Body temperature ≥ 38.0 °C attributable to the disease
• Background treatment with stable dose of ≤ 1 mg/kg/d (Max 60 mg/d) of oral prednisolone or equivalent for at least 3 days prior to enrollment is permitted.
• If currently on methotrexate (MTX) treatment, the dose must be stable for at least 4 weeks prior to enrollment. Maximum dose allowed is 20 mg/m2/week. If the patient discontinued MTX prior to enrollment, the discontinuation is required to be at least 4 weeks prior to enrollment.
• Female patients of childbearing potential and male patient with female partner of childbearing potential must use an effective method of contraception during the study (abstinence being a possible option). A negative pregnancy test prior to enrollment is also required.
• In case of use of oral contraception, women should have been stable on the same brand (or generic equivalent) for a minimum of 3 months before taking study treatment.

You may not qualify if:

• Previous enrollment to this study
• Participation in another clinical interventional study 30 days prior to enrollment.
• Treatment with an investigational drug within 5 half-lives prior to enrollment.
• Use of the following therapies prior to enrollment:
• Narcotic analgesics within 24 hours prior to enrollment.
• Dapsone 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.
• Leflunomide, infliximab or adalimumab within 8 weeks prior to enrollment.
• Thalidomide within 72h (3 days) prior to enrollment, cyclosporine within 5 weeks prior to enrollment, tacrolimus hydrate within 2 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 within 48h (2 days) prior to enrollment, Janus kinase (JAK) inhibitors within 5 half-lives prior to enrollment, or any other immunosuppressant within 12 weeks prior to enrollment.
• Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medication within 5 half-lives prior to enrollment.
• Rituximab within 26 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, 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:

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• Tigermed Consulting Co., Ltd: collaborator

MeSH Terms

Conditions

Arthritis, Juvenile; Still's Disease, Adult-Onset

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 16, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share