Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement. (TILT2)

Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Giant Cell Arteritis (GCA)

Detailed Description

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.

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. 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.

Treatment with upadacitinib will be initiated at the time of patient inclusion (one 15 mg tablet per day) and will be maintained for 104 weeks. 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. Clinical, biological, and radiological efficacy data, as well as treatment safety, will be prospectively analyzed at 3, 6, 12, and 24 months.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: David Saadoun, Professor; Phone Number: +33142178042; Email: david.saadoun@aphp.fr

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Clinique Axium - Aix-en-provence
    • Contact: Thomas SENE, MD; Phone Number: 0442957153; Email: dr.sene.axium@almaviva-sante.com
  • Caen, France, 14000
    • CHU Caen Normandie
    • Contact: DE BOYSSON Hubert, MD; Phone Number: 02 31 06 46 78; Email: deboysson-h@chu-caen.fr
  • Dijon, France
    • Chu de Dijon
    • Contact: Samson Maxime, Pr; Phone Number: +33380293432
  • Le Mans, France
    • CH du Mans
    • Contact: LOZAC'H Pierre, MD; Phone Number: +33243432799
  • Marseille, France, 13915
    • APHM_Hôpital Nord
    • Contact: Brigitte Granel, MD; Phone Number: 0491968711; Email: Brigitte.granel@ap-hm.fr
  • Marseille, France
    • APHM_Hôpital La Conception
    • Contact: JARROT Pierre-André, MD; Phone Number: +33 4 91 38 35 22; Email: Pierre.JARROT@ap-hm.fr
  • Melun, France, 77000
    • GHSIF Melun
    • Contact: Nabil Belfeki, MD; Phone Number: 0181741818; Email: nabil.belfeki@ghsif.fr
  • Montfermeil, France, 93370
    • GHI Le Raincy Montfermeil
    • Contact: Dellal Azeddine, MD; Phone Number: 01. 41.70. 81.25; Email: azeddine.dellal@ght-gpne.fr
  • Nantes, France, 44000
    • CHU Nantes - Hôtel-Dieu
    • Contact: Espitia Olivier, MD; Phone Number: 02 40 08 33 55; Email: Olivier.espitia@chu-nantes.fr
  • Paris, France, 75012
    • APHP_Hôpital St Antoine
    • Contact: Arsene Mekinian, Professor; Phone Number: +331 49 28 23 92; Email: arsene.mekinian@aphp.fr
  • Paris, France, 75013
    • APHP_ Hôpital Pitié-Salpêtrière
    • Contact: David Saadoun, Professor; Phone Number: +33142178042; Email: david.saadoun@aphp.fr
  • Rouen, France
    • CHU Rouen_Hôpital Charles Nicolle
    • Contact: Mathilde LECLERQ, MD; Phone Number: 0232889003.; Email: Mathilde.Leclercq@chu-rouen.fr
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • APHP_Hopital Lariboisière
      • Contact: Chloé Comarmond, Professor; Phone Number: +33149958127; Email: chloe.comarmondortoli@aphp.fr
    • Paris, Île-de-France Region, France, 75018
      • APHP_Hôpital Bichat
      • Contact: karim Sacre, Professor; Phone Number: +33140258316; Email: karim.sacre@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients achieving remission of GCA	the proportion of patients achieving remission of GCA at week 24.	Week 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of relapses	Cumulative incidence of relapses at weeks 12, 24, 36, 52, and 104;	Weeks 12, 24, 36, 52, and 104;
Cumulative incidence of GCA remission according to the EULAR consensus definitions	Cumulative incidence of GCA remission according to the EULAR consensus definitions at weeks 12, 36, 52, and 104;	Weeks 12, 36, 52, and 104;
Cumulative prednisone dose	Cumulative prednisone dose at weeks 12, 24, 36, 52, and 104;	Weeks 12, 24, 36, 52, and 104;
Cumulative incidence of adverse events and serious adverse events	Cumulative incidence of adverse events and serious adverse events at weeks 12, 24, 36, 52, and 104	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)	Proportion of aortic inflammatory activity as well as radiological vascular progression (i.e., new aortic dilatation and/or stenosis) at weeks 24, 52, and 104, assessed by CT angiography, MR angiography, and/or PET-scan;	Weeks 24, 52, and 104,
Cumulative incidence rate of the need for vascular, endovascular, or surgical revascularization procedures due to inflammatory activity	Cumulative incidence rate of the need for vascular, endovascular, or surgical revascularization procedures due to inflammatory activity at weeks 24, 52, and 104.	Weeks 24, 52, and 104.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2030

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Efficacy; Upadacitinib; Giant Cell Arteritis (GCA) .
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis
• Other Study ID Numbers: TILT2; 2025-A02745-44 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No