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Upadacitinib for giant cell arteritis affecting large blood vessels

Looks at upadacitinib in adults with active giant cell arteritis of large vessels.

Key facts

Who runs it
Groupe français d'étude des Maladies Inflammatoires de loeil
Where
France14 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.
Status
Not yet recruiting
People taking part
80 people, planned
Started
1 Mar 2026
Expected to end
30 Mar 2030
Type of study
Observational
Record updated
21 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

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.

Age
Over 18 years
Sex
All sexes
Disease stage
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.
Earlier treatment
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.

Main reasons for not taking part

  • 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

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

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

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.
Plain-language title
Upadacitinib for giant cell arteritis affecting large blood vesselsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
21 January 2026