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.
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
80
Clinique Axium - Aix-en-provence
Aix-en-Provence, France
CHU Caen Normandie
Caen, France
CHU de Dijon
Dijon, France
CH du Mans
Le Mans, France
APHM_Hôpital Nord
Marseille, France
APHM_Hôpital La Conception
Marseille, France
GHSIF Melun
Melun, France
GHI Le Raincy Montfermeil
Montfermeil, France
CHU Nantes - Hotel-Dieu
Nantes, France
APHP_Hôpital St Antoine
Paris, France
...and 4 more locations
The proportion of patients achieving remission of GCA
the proportion of patients achieving remission of GCA at week 24.
Time frame: Week 24.
Cumulative incidence of relapses
Cumulative incidence of relapses at weeks 12, 24, 36, 52, and 104;
Time frame: 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;
Time frame: Weeks 12, 36, 52, and 104;
Cumulative prednisone dose
Cumulative prednisone dose at weeks 12, 24, 36, 52, and 104;
Time frame: 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
Time frame: 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;
Time frame: 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.
Time frame: Weeks 24, 52, and 104.
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