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Real-World data sought on upadacitinib for rare artery disease

NCT ID NCT07354906

Knowledge-focused Sponsor: Groupe français d'étude des Maladies Inflammatoires de loeil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 80 adults with giant cell arteritis (GCA) affecting large arteries who are taking upadacitinib as part of their routine care. Researchers will collect data from medical records to see how many achieve remission at 24 weeks and track relapses over 2 years. No extra visits or tests are added, so participation does not change usual treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with giant cell arteritis (GCA) and active aortitis, with an indication for treatment with an anti-JAK agent within the scope of the marketing authorization for GCA.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell arteritis (GCA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM_Hôpital La Conception

    Marseille, France

  • APHM_Hôpital Nord

    Marseille, 13915, France

  • APHP_ Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • APHP_Hopital Lariboisière

    Paris, Île-de-France Region, 75010, France

  • APHP_Hôpital Bichat

    Paris, Île-de-France Region, 75018, France

  • APHP_Hôpital St Antoine

    Paris, 75012, France

  • CH du Mans

    Le Mans, France

  • CHU Caen Normandie

    Caen, 14000, France

  • CHU Nantes - Hotel-Dieu

    Nantes, 44000, France

  • CHU Rouen_Hôpital Charles Nicolle

    Rouen, France

  • CHU de Dijon

    Dijon, France

  • Clinique Axium - Aix-en-provence

    Aix-en-Provence, 13100, France

  • GHI Le Raincy Montfermeil

    Montfermeil, 93370, France

  • GHSIF Melun

    Melun, 77000, France

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