Giant Cell Arteritis (GCA)TILT2NCT07354906
Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.
An observational study of Giant Cell Arteritis (GCA), run by Groupe français d'étude des Maladies Inflammatoires de loeil at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 14 sitesFrance
- Study dates
- 1 Mar 2026to 30 Mar 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites
Clinique Axium - Aix-en-provence
Aix-en-Provence, 13100
Thomas SENE, MD, 0442957153, dr.sene.axium@almaviva-sante.com
CHU Caen Normandie
Caen, 14000
DE BOYSSON Hubert, MD, 02 31 06 46 78, deboysson-h@chu-caen.fr
CHU de Dijon
Dijon
Samson Maxime, Pr, +33380293432
CH du Mans
Le Mans
LOZAC'H Pierre, MD, +33243432799
APHM_Hôpital Nord
Marseille, 13915
Brigitte Granel, MD, 0491968711, Brigitte.granel@ap-hm.fr
APHM_Hôpital La Conception
Marseille
JARROT Pierre-André, MD, +33 4 91 38 35 22, Pierre.JARROT@ap-hm.fr
GHSIF Melun
Melun, 77000
Nabil Belfeki, MD, 0181741818, nabil.belfeki@ghsif.fr
GHI Le Raincy Montfermeil
Montfermeil, 93370
Dellal Azeddine, MD, 01. 41.70. 81.25, azeddine.dellal@ght-gpne.fr
CHU Nantes - Hotel-Dieu
Nantes, 44000
Espitia Olivier, MD, 02 40 08 33 55, Olivier.espitia@chu-nantes.fr
APHP_Hôpital St Antoine
Paris, 75012
Arsene Mekinian, Professor, +331 49 28 23 92, arsene.mekinian@aphp.fr
APHP_ Hôpital Pitié-Salpêtrière
Paris, 75013
David Saadoun, Professor, +33142178042, david.saadoun@aphp.fr
APHP_Hopital Lariboisière
Paris, Île-de-France Region, 75010
Chloé Comarmond, Professor, +33149958127, chloe.comarmondortoli@aphp.fr
APHP_Hôpital Bichat
Paris, Île-de-France Region, 75018
karim Sacre, Professor, +33140258316, karim.sacre@aphp.fr
CHU Rouen_Hôpital Charles Nicolle
Rouen
Mathilde LECLERQ, MD, 0232889003., Mathilde.Leclercq@chu-rouen.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Giant Cell Arteritis (GCA)
- Keywords
- Giant Cell Arteritis (GCA) ., Upadacitinib, Efficacy
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving remission of GCA
the proportion of patients achieving remission of GCA at week 24.
Measured: Week 24.
Secondary outcomes (6)
Cumulative incidence of relapses
Cumulative incidence of relapses at weeks 12, 24, 36, 52, and 104;
Measured: 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;
Measured: Weeks 12, 36, 52, and 104;
Cumulative prednisone dose
Cumulative prednisone dose at weeks 12, 24, 36, 52, and 104;
Measured: 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
Measured: 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;
Measured: 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.
Measured: Weeks 24, 52, and 104.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354906
- Sponsor's protocol ID
- TILT2
- Other IDs
- 2025-A02745-44
- Acronym
- TILT2
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.
- ClinicalTrials.gov ID
- NCT07354906
- Acronym / sponsor ID
- TILT2 / TILT2
- Conditions
- Giant Cell Arteritis (GCA)
- Keywords
- Giant Cell Arteritis (GCA) ., Upadacitinib, Efficacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
- Platelets < 50 × 10³/mm³; Neutropenia < 1,000/mm³; Hemoglobin < 8 g/dL; History of thromboembolic disease; History of severe cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients achieving remission of GCA
Time frame: Week 24.
the proportion of patients achieving remission of GCA at week 24.
6 secondary outcomes
Cumulative incidence of relapses
Time frame: Weeks 12, 24, 36, 52, and 104;
Cumulative incidence of GCA remission according to the EULAR consensus definitions
Time frame: Weeks 12, 36, 52, and 104;
Cumulative prednisone dose
Time frame: Weeks 12, 24, 36, 52, and 104;
Cumulative incidence of adverse events and serious adverse events
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)
Time frame: Weeks 24, 52, and 104,
Cumulative incidence rate of the need for vascular, endovascular, or surgical revascularization procedures due to inflammatory activity
Time frame: Weeks 24, 52, and 104.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis (GCA), run by Groupe français d'étude des Maladies Inflammatoires de loeil at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Saadoun, Professor (+33142178042, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving remission of GCA (time frame: Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.