Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial
Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.
Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.
Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.
In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.
During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.
Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.
As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Huaxiang Wu
- Número de teléfono: 0086-13757118395
- Correo electrónico: wuhx8855@zju.edu.cn
Ubicaciones de estudio
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Fuzhou, Porcelana
- Fuzhou University Affiliated Provincial Hospital
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Contacto:
- Fei Gao
- Número de teléfono: 0086-13665013469
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Hangzhou, Porcelana
- Zhejiang Hospital
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Contacto:
- Fang Yuan
- Número de teléfono: 0086-18072963566
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Hangzhou, Porcelana
- Tongde Hospital of Zhejiang Province
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Contacto:
- Qin Chen
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Huzhou, Porcelana
- Changxin People's Hospital
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Contacto:
- Yingying Wang
- Número de teléfono: 0086-13705790575
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Jinhua, Porcelana
- Jinhua Municipal Central Hospital
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Contacto:
- Li Hua
- Número de teléfono: 0086-13758992315
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Ningbo, Porcelana
- Ningbo Medical Center Lihuili Hospital
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Contacto:
- Li Zhou
- Número de teléfono: 0086-13858287828
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Wenzhou, Porcelana
- The Second Affiliated Hospital of Wenzhou Medical University
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Contacto:
- Hong Wang
- Número de teléfono: 0086-13957756514
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Wenzhou, Porcelana
- The First People's Hospital of Wenlin
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Contacto:
- Yongjun Chen
- Número de teléfono: 0086-13958633696
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Zhejiang Provincial People's Hospital
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Contacto:
- Lijuan Wang
- Número de teléfono: 0086-13567134447
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Hangzhou, Zhejiang, Porcelana
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Contacto:
- Huaxiang Wu
- Número de teléfono: 0086-13757118395
- Correo electrónico: wuhx8855@zju.edu.cn
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Hangzhou, Zhejiang, Porcelana
- The Second Affiliated Hospital of Zhejiang Chinese Medical University
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Contacto:
- Kepeng Yang
- Número de teléfono: 0086-17826873536
- Correo electrónico: ykp1029@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 to 75 years (inclusive), male or female;**
- Meet the 2015 ACR/EULAR Gout Classification Criteria;**
- Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;**
- Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；
Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions:
Patients currently receiving ULT with a stable regimen for≥14 days may continue their stable dosing; adjustments (including medication switch, dose reduction, or discontinuation) are permitted if the investigator assesses intolerance, poor efficacy, or achievement of target serum uric acid levels;
- For patients not on ULT or those on ULT but not stable for 14 days before enrollment, the investigator will decide whether to initiate ULT based on uric acid levels. In principle, allopurinol-naive patients should not be prescribed allopurinol in this study;
- Voluntarily signed the Informed Consent Form (ICF).
Exclusion Criteria:
- History of hypersensitivity to the study drug or similar classes of drugs;
- Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
- Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
- Confirmed secondary gout;
- Confirmed or suspected rheumatoid arthritis, infectious/septic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.);
- Presence of infection requiring systemic treatment within 7 days prior to screening;
- Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study;
- History of malignancy within 5 years prior to screening, except for adequately treated or excised cutaneous basal cell carcinoma or Stage I squamous cell carcinoma;
- History of systemic irradiation or total lymphoid irradiation; history of stem cell therapy or any type of bone marrow transplantation; history of solid organ transplantation; or long-term systemic use of immunosuppressants;
- History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
History of clinically significant diseases, including:
Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs; History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG ;
- Confirmed active tuberculosis infection;
- Receiving renal dialysis;
Laboratory abnormalities at screening as follows:
White blood cellcount or absolute neutrophil count below the lower limit of normal at the study site; Platelet count ≤100×10^9/L; Total bilirubin > 1.5 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²; Triglycerides > 5.7 mmol/L;
- Pregnant or breastfeeding women;
- Women of childbearing potential who refuse to use highly effective contraception during the study;
- Use of any investigational drug or participation in other interventional clinical trials within 1 month prior to screening (participation in observational studies only is permitted);
- History of drug and/or alcohol abuse or psychiatric disorders;
- Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Regular dosing group
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A 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
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Otro: On-demand dosing group
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Following randomization, patients will remain under continuous observation.
In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Mean number of gout flares over 24 weeks after randomization.
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Time to resolution of the first gout flare
Periodo de tiempo: 24 weeks after randomization.
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24 weeks after randomization.
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Time to first gout flare
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Proportion of patients with at least one gout flare
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Patient treatment satisfaction scores
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Incidence of adverse events and serious adverse events.
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from baseline in CRP and hsCRP
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in IL-6、IL-1β and TNF-α
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in ESR
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Percentage change from baseline in tophus diameter
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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change from baseline in serum urate
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Pain VAS score at the first gout flare
Periodo de tiempo: 24 weeks after randomization
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24 weeks after randomization
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20260160
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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