Still's Disease, Adult-Onset
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of firsekibart versus anakinra in patients with AOSD.
Interventions
BIOLOGICALFirsekibart
Firsekibart will be administered according to the protocol
BIOLOGICALAnakinra
Anakinra will be administered according to the protocol
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: This study will include subjects aged 18 to 75 years (inclusive), regardless of gender. * Subjects must be willing to participate in the study and voluntarily sign an informed consent form. * Diagnosis of AOSD will be based on the Yamaguchi criteria: Major criteria: (1) Fever ≥39°C lasting for ≥1 week; (2) Arthralgia lasting for ≥2 weeks; (3) Typical rash; (4) White blood cell count ≥10×10\^9/L with neutrophils ≥80%. Minor criteria: (1) Sore throat or pharyngitis; (2) Lymphadenopathy and/or splenomegaly; (3) Abnormal liver function; (4) Negative rheumatoid factor and antinuclear antibody.
Exclusion criteria
(1) Infectious diseases (especially sepsis and EBV infection); (2) Malignancies (especially lymphoma); (3) Other rheumatic diseases (particularly systemic vasculitis). After excluding the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving clinical inactive disease (CID) at Week 24, where CID is defined as the absence of Still's disease-related symptoms with normal ESR or CRP levels. | At Week 24 from initiation of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving afebrile status with either ≥50% reduction in CRP levels or CRP within normal range at Weeks 2, 4, and 8. | At Weeks 2, 4, and 8 after treatment initiation | Efficacy Endpoints |
| Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.2 mg/kg/day at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.1 mg/kg/day at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Proportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoids | At Week 24 after treatment initiation | Efficacy Endpoints |
| Proportion of subjects without disease relapse at Weeks 12 and 24. | At Weeks 12 and 24 after treatment initiation | Efficacy Endpoints |
| ACR30, ACR50, ACR70, and ACR90 response rates at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Change from baseline in ferritin levels at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Change from baseline in cytokine levels (including sIL-2R) at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Change from baseline in ESR at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Change from baseline in CRP levels at Weeks 2, 4, 8, 12, 16, 20, and 24 | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Change from baseline in Pouchot score at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints. Pouchot score ranges from 0 to 12 points, with higher scores indicating a poorer outcome. |
| Change from baseline in glucocorticoid dose at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion, an average of 1 year | — |
Countries
China
Contacts
CONTACTChengde Yang
CONTACTQiongyi Hu
Outcome results
None listed