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

NCT07354906 | Not Yet Recruiting

• 2 other identifiers: TILT22025-A02745-44
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 14

Brief Summary

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. 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.

Conditions

Giant Cell Arteritis (GCA)

Keywords

Giant Cell Arteritis (GCA) .; Upadacitinib; Efficacy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving remission of GCA

  the proportion of patients achieving remission of GCA at week 24.

  Week 24.

Secondary Outcomes (6)

• Cumulative incidence of relapses

  Weeks 12, 24, 36, 52, and 104;

• Cumulative incidence of GCA remission according to the EULAR consensus definitions

  Weeks 12, 36, 52, and 104;

• Cumulative prednisone dose

  Weeks 12, 24, 36, 52, and 104;

• Cumulative incidence of adverse events and serious adverse events

  Weeks 12, 24, 36, 52, and 104

• Proportion of aortic inflammatory activity as well as radiological vascular progression (i.e., new aortic dilatation and/or stenosis)

  Weeks 24, 52, and 104,

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe français d'étude des Maladies Inflammatoires de loeil: lead

Study Sites (14)

Clinique Axium - Aix-en-provence

Aix-en-Provence, 13100, France

Location

CHU Caen Normandie

Caen, 14000, France

Location

CHU de Dijon

Dijon, France

Location

CH du Mans

Le Mans, France

Location

APHM_Hôpital Nord

Marseille, 13915, France

Location

APHM_Hôpital La Conception

Marseille, France

Location

GHSIF Melun

Melun, 77000, France

Location

GHI Le Raincy Montfermeil

Montfermeil, 93370, France

Location

CHU Nantes - Hotel-Dieu

Nantes, 44000, France

Location

APHP_Hôpital St Antoine

Paris, 75012, France

Location

APHP_ Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

CHU Rouen_Hôpital Charles Nicolle

Rouen, France

Location

APHP_Hopital Lariboisière

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

Location

APHP_Hôpital Bichat

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

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

David Saadoun, Professor

CONTACT

+33142178042; david.saadoun@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2030
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (14)