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A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD (SATURN)

12. august 2026 opdateret af: Junwei Hao, MD

Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study

This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Zheng Liu, MD, PhD
  • Telefonnummer: +86 13754093891
  • E-mail: lzwcy@xwhosp.org

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100053
        • Rekruttering
        • Xuanwu Hospital Capital Medical University
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Xixi Yang, MD, PhD

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with NMOSD (AQP4-IgG-positive) at early phase of an NMOSD attack, and age ≥ 18 years. The EDSS score ≤ 8.5 during an acute relapse in NMOSD.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of AQP4-IgG-positive NMOSD* and age ≥ 18 years; EDSS score ≤ 8.5 during an acute relapse in NMOSD patients; NMOSD patients experiencing an acute relapse who are scheduled to receive or are currently receiving recommended acute-phase treatments-including intravenous methylprednisolone, IVIG, PE, or PA; Receiving Satralizumab treatment; Patient understands the study procedures and has signed the informed consent form indicating willingness to participate in the study.

Exclusion Criteria:

  • Patients with NMOSD who received other biologics (e.g., rituximab, inebilizumab, tocilizumab, eculizumab) either within the past 6 months prior to this acute exacerbation or during the current acute phase; Patients with contraindications to Satralizumab, including: known allergy to Satralizumab or any inactive ingredient, active Hepatitis B infection, active or therapy-naive latent tuberculosis; Pregnant or lactating women; Patients with concomitant Neoplasm malignant or other severe diseases; Patients currently enrolled in other interventional clinical studies; Patients assessed by the investigator/research staff as having a Critical illness or any Mental disorder or Cognitive disorder that may interfere with the study and who are unable to complete the key assessments required by this protocol; patients assessed by the investigator/research staff as unlikely to attend scheduled follow-up assessments under routine clinical care.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Satralizumab Treatment Group
NMOSD patients receiving Satralizumab at early phase of an NMOSD attack
Medicin: Satralizumab
As recommended in the prescribing information, patients will receive subcutaneous satralizumab Injection as part of their routine treatment. The loading dose is 120 mg administered at Weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks. Maintenance treatment is recommended for a minimum duration of 24 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EDSS
Tidsramme: 24 weeks
Change in EDSS score between at baseline and at 6 months of treatment
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EDSS
Tidsramme: 12 weeks
Change in EDSS score between at baseline and at 3 months of treatment
12 weeks
mRS
Tidsramme: 12 weeks
Changes in mRS between at baseline and at 3 months of treatment
12 weeks
EQ-5D
Tidsramme: 12 weeks
Changes in EQ-5D between at baseline and at 3 months of treatment
12 weeks
ADL score
Tidsramme: 12 weeks
Changes in ADL score between at baseline and at 3 months of treatment
12 weeks
mRS
Tidsramme: 24 weeks
Changes in mRS between at baseline and at 6 months of treatment
24 weeks
EQ-5D
Tidsramme: 24 weeks
Changes in EQ-5D between at baseline and at 6 months of treatment
24 weeks
ADL score
Tidsramme: 24 weeks
Changes in ADL score between at baseline and at 6 months of treatment
24 weeks
relapse
Tidsramme: 24 weeks
Relapse events occurring within 6 months of treatment
24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Junwei Hao, MD

Samarbejdspartnere

The Second Hospital of Hebei Medical University
Shandong Provincial Hospital
The First Hospital of Hebei Medical University
First Affiliated Hospital of Harbin Medical University
Chifeng Municipal Hospital

Efterforskere

  • Ledende efterforsker: Junwei Hao, MD, PhD, Xuanwu Hospital Department of Neurology

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 (Faktiske)

20. juli 2026

Primær færdiggørelse (Anslået)

20. juli 2027

Studieafslutning (Anslået)

20. januar 2028

Datoer for studieregistrering

Først indsendt

7. august 2026

Først indsendt, der opfyldte QC-kriterier

12. august 2026

Først opslået (Faktiske)

13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • xw-[2025]291-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual's age, gender, EDSS, mRS, ADL, EQ-5D, laboratory parameters and adverse event records, etc.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner