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Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.

A legfontosabb adatok

Ki végzi
Groupe français d'étude des Maladies Inflammatoires de loeil
Hol
Franciaország14 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
80 fő, tervezett
Kezdés
2026. márc. 1.
Várható befejezés
2030. márc. 30.
A vizsgálat típusa
Megfigyeléses
A regiszteradat frissítve
2026. január 21.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with giant cell arteritis (GCA) and active inflammation of the aorta who are starting upadacitinib. It only collects data from routine care.

Életkor
Over 18 years
Nem
All sexes
A betegség stádiuma
Newly diagnosed or relapsing GCA by the 2022 ACR/EULAR criteria, with active aortitis (inflamed aorta) seen on CT angiography, MR angiography and/or PET-CT.
Korábbi kezelés
Tocilizumab did not work, was not tolerated, or could not be used. People who did not respond to or could not tolerate an earlier anti-JAK drug cannot join.

A részvétel fő kizáró okai

  • Pregnancy or breastfeeding
  • HIV, hepatitis C, positive hepatitis B surface antigen (HBsAg), or past severe immune weakness
  • Active tuberculosis; latent tuberculosis treated for at least 3 weeks is allowed
  • Cancer within the past 5 years, past blood clots, or past severe heart and blood vessel disease
  • Severe kidney problems (creatinine clearance < 30 mL/min/1.73 m²), liver enzymes AST or ALT ≥ 5 times the upper limit of normal, platelets < 50 × 10³/mm³, neutrophils < 1,000/mm³, or hemoglobin < 8 g/dL

A regiszter feltételei, szó szerint

Mind a 2 feltétel megnézéseKevesebb

Ki vehet részt

  • Patients aged over 18 years; Signed informed consent; Affiliation with the French national social security system; Diagnosis of newly diagnosed or relapsing GCA according to the 2022 ACR/EULAR criteria; Active aortitis related to GCA demonstrated by imaging (CT angiography, MR angiography, and/or PET-CT); Indication for treatment with an anti-JAK agent within the scope of the marketing authorization for GCA: failure of, intolerance to, or contraindication to tocilizumab therapy; No contraindication to JAK inhibitors

Ki nem vehet részt

  • Pregnancy or breastfeeding (for women of childbearing potential, a negative serum pregnancy test will be required); History of severe immunosuppression, HIV infection, hepatitis C virus (HCV), or positive hepatitis B surface antigen (HBsAg); Non-response to or intolerance of a previous anti-JAK treatment; Positive QuantiFERON test (QFT-TB Gold In-Tube) indicating active tuberculosis (latent tuberculosis under treatment for at least 3 weeks may be included); Receipt of live vaccines within the 3 months preceding treatment initiation; History of malignancy within the past 5 years; Severe renal impairment (creatinine clearance < 30 mL/min/1.73 m²); Hepatic dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≥ 5 times the upper limit of normal; Abnormal blood counts:; Platelets < 50 × 10³/mm³; Neutropenia < 1,000/mm³; Hemoglobin < 8 g/dL; History of thromboembolic disease; History of severe cardiovascular disease

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Participants will be followed as part of the usual management of their disease. No modifications will be made (no additional visits, examinations, or questionnaires). The safety and well-being of participants will therefore remain unchanged.

A teljes eredeti leírásKevesebb

The participant will be informed about the study during one of their routine care visits. The information will be provided by the investigator, and the participant's non-opposition to participation in the study will be obtained.

The participant will continue to be followed as part of their usual care.

Data will then be collected from the participant's medical record (including medical reports, original laboratory test results, imaging reports and medical examinations, and nursing records) for the period of participation in the research, solely for the purpose of meeting the objectives of the research.

The data collected will consist of information from the patient's medical record as part of their routine follow-up and will be strictly necessary to address the primary and secondary objectives of the study. The following data will be collected: demographic data (age, sex, weight, height); clinical data (medical history, diagnosed condition, disease activity), treatments, biological data, imaging data, and adverse events. No genetic data will be collected as part of the study. There will be no transfer of data abroad, and no additional questionnaires, examinations, or visits will be added by the research.

A vizsgálat csoportja

  • Multicenter cohort evaluating the safety and efficacy of upadacitinib in patients with GCA condition

    This is an observational, multicenter cohort evaluating the safety and efficacy of upadacitinib in patients with giant cell arteritis (GCA). Patient treatment and follow-up will be conducted in accordance with routine clinical care. No additional visits or examinations will be added for the purposes of the study. Participants will be followed as part of the usual management of their disease. No modifications will be made (no additional visits, examinations, or questionnaires). The safety and well-being of participants will therefore remain unchanged. Patients will then be followed and managed according to routine care (visits and examinations). Routine care includes: * A clinical assessment of efficacy and safety at weeks 12, 24, 36, 52, and 104; * Oral prednisone treatment at the initial doses recommended by international and French guidelines, in accordance with routine care.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. január 21.