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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NCT07706868 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-07-16

No results posted yet for this study

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)

Interventions

DRUG

Anakinra (Kineret®)

Subcutaneous injections once daily for 48 weeks

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-09-30
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706868 on ClinicalTrials.gov