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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe français d'étude des Maladies Inflammatoires de loeil

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Multicenter cohort evaluating the safety and efficacy of upadacitinib in patients with GCA condition

Trial outcomes

Primary outcomes

1

The proportion of patients achieving remission of GCA

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

Time frame
Week 24.

Secondary outcomes

1

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;
2

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;
3

Cumulative prednisone dose

Cumulative prednisone dose at weeks 12, 24, 36, 52, and 104;

Time frame
Weeks 12, 24, 36, 52, and 104;
4

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

Other outcomes

Sponsors and contacts

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