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24-Week Recurrence Rate of Gout Following Firsekibart Treatment

2. juni 2026 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

The 24-Week Recurrence Rate of Acute Gouty Arthritis in Patients Treated With Firsekibart: A Multicenter, Prospective, Real-World Study

Study Objective: To evaluate the 24-week recurrence rate and safety of Firsekibart in patients with acute gouty arthritis in a real-world clinical setting.

Study Methods: This study utilizes a multicenter, prospective, observational, real-world study design. The study plans to enroll all cases that receive Firsekibart for the first time and meet the inclusion and exclusion criteria between March 1, 2026, and February 28, 2029, with a follow-up period of 24 weeks. This study will not intervene in clinical treatment regimens; it will solely record and analyze the diagnosis and treatment data that actually occur.

Study Outcomes: Primary Outcome: The proportion of patients with at least one gout recurrence (flare) at 24 weeks.Secondary Outcomes: 1. Average number of gout recurrences over 24 weeks; 2. Time to the first gout recurrence; 3. Duration of the first gout recurrence; 4. Incidence of adverse events (AEs) and serious adverse events (SAEs).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

264

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Fuzhou, Kina
        • Fuzhou University Affiliated Provincial Hospital
        • Kontakt:
          • Fei Gao
          • Telefonnummer: 0086-13665013469
      • Hangzhou, Kina
        • Zhejiang Provincial People's Hospital
        • Kontakt:
          • Lijuan Wang
          • Telefonnummer: 0086-13567134447
      • Hangzhou, Kina
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Kontakt:
      • Hangzhou, Kina
        • Zhejiang Hospital
        • Kontakt:
          • Fang Yuan
          • Telefonnummer: 0086-18072963566
      • Hangzhou, Kina
        • The Second Affiliated Hospital of Zhejiang Chinese Medical University
        • Kontakt:
      • Hangzhou, Kina
        • Tongde Hospital of Zhejiang Province
        • Kontakt:
          • Qin Chen
          • Telefonnummer: 0086-15869192858
      • Huzhou, Kina
        • Changxin People's Hospital
        • Kontakt:
          • Yingying Wang
      • Jinhua, Kina
        • Jinhua municipal central hospital
        • Kontakt:
          • Li Hua
          • Telefonnummer: 0086-13758992315
      • Ningbo, Kina
        • Ningbo medical center lihuili hospital
        • Kontakt:
          • Li Zhou
          • Telefonnummer: 0086-13858287828
      • Wenzhou, Kina
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
          • Hong Wang
          • Telefonnummer: 0086-13957756514
      • Wenzhou, Kina
        • The First People's Hospital of Wenlin
        • Kontakt:
          • Yongjun Cheng
          • Telefonnummer: 0086-13958633696

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18 to 75 years (inclusive), male or female;
  2. Meet the 2015 ACR/EULAR Gout Classification Criteria;
  3. Two or more acute gout flares within a year;
  4. In the acute phase of a gout flare;
  5. Voluntarily signed the Informed Consent Form (ICF).

Exclusion Criteria:

  1. History of hypersensitivity to the study drug or similar classes of drugs;
  2. Pregnant or breastfeeding women;
  3. 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 ;
  4. Confirmed active tuberculosis infection;
  5. History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
  6. Presence of infection requiring systemic treatment within 7 days prior to screening;
  7. 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;
  8. Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Eksperimentel gruppe
Medicin: Firsekibart
A 200mg subcutaneous injection of firsekibart was administered within 12 hours of the onset of an acute gout flare.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The proportion of patients experiencing at least one gout recurrence within 24 weeks.
Tidsramme: From enrollment to the end of treatment at 24 weeks.
From enrollment to the end of treatment at 24 weeks.

Sekundære resultatmål

Resultatmål
Tidsramme
Mean number of gout flares over 24 weeks.
Tidsramme: From enrollment to the end of treatment at 24 weeks
From enrollment to the end of treatment at 24 weeks
Time to resolution of the first gout flare
Tidsramme: From enrollment to the end of treatment at 24 weeks
From enrollment to the end of treatment at 24 weeks
Time to first gout recurrence
Tidsramme: From enrollment to the end of treatment at 24 weeks
From enrollment to the end of treatment at 24 weeks
Incidence of adverse events and serious adverse events.
Tidsramme: From enrollment to the end of treatment at 24 weeks
From enrollment to the end of treatment at 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. maj 2026

Primær færdiggørelse (Anslået)

28. august 2029

Studieafslutning (Anslået)

28. august 2029

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026-0160

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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