About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The proportion of patients achieving remission of GCA
the proportion of patients achieving remission of GCA at week 24.
Secondary outcomes
Cumulative incidence of relapses
Cumulative incidence of relapses at 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;
Cumulative prednisone dose
Cumulative prednisone dose at 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
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: