Giant Cell Arteritis (GCA)TACTIC-GCANCT07459335
TArget Trial Emulation Comparing Effectiveness of Tocilizumab vs Methotrexate In Corticosteroid-Treated GCA Patients
An observational study of Giant Cell Arteritis (GCA) and Cardiovascular Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 2 sites in France.
Trial summary
This nationwide observational study emulates a target trial to compare the effect of tocilizumab versus methotrexate initiation on major adverse cardiovascular events (MACE) in patients with incident giant cell arteritis using the French National Health Data System (SNDS). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Giant Cell Arteritis (GCA), Cardiovascular Diseases
- How many people
- 1,667 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2012to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥50 years hospitalized for incident giant cell arteritis in France identified from the SNDS database.
Who may be able to join
- Age ≥50 years Incident hospitalization for giant cell arteritis Initiation of tocilizumab or methotrexate within 6 months Received systemic corticosteroids ≥20 mg/day within 30 days following hospital discharge
Who cannot join
- Prior use of tocilizumab or methotrexate Age >90 years Length of stay >30 days Not discharged home Prior aortic disease or vascular imaging within 2 years Initiation of both treatments during grace period
Trial locations and contacts
2 sites in 1 country.
France2 sites
APHP_ Hôpital Saint-Antoine
Paris, 75012
APHP_ Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Comparative Effect of Tocilizumab Versus Methotrexate on Major Adverse Cardiovascular Events in Giant Cell Arteritis: A Nationwide Target Trial Emulation Using the French SNDS
This nationwide observational study emulates a target trial to compare the effect of tocilizumab versus methotrexate initiation on major adverse cardiovascular events (MACE) in patients with incident giant cell arteritis using the French National Health Data System (SNDS).
Read the detailed description
Study Design and Data Source This study is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. We emulated a hypothetical randomized trial comparing two treatment strategies: initiation of tocilizumab versus methotrexate within 6 months after hospital discharge for incident giant cell arteritis. Eligible patients aged ≥50 years hospitalized for incident GCA between 2012 and 2024 were included.
Statistical Analysis A clone-censor-weight approach was used to account for treatment initiation timing and avoid immortal time bias. Inverse probability of censoring weights were applied to adjust for informative censoring. Treatment effects were estimated using weighted Kaplan-Meier methods and Cox proportional hazards models.
Outcomes The primary outcome was the occurrence of major adverse cardiovascular events (MACE), defined as myocardial infarction, ischemic stroke, or all-cause death. Secondary outcomes included individual cardiovascular components, aortic events, and major vascular relapse.
Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
- Medical subject headings
- Giant Cell Arteritis, Cardiovascular Diseases
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 |
|---|---|---|
| Tocilizumab group | Patients initiating tocilizumab within 6 months after discharge for incident GCA. | |
| Methotrexate group | Patients initiating methotrexate within 6 months after discharge for incident GCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
Measured: 2 years
Secondary outcomes (9)
Coronary events
Coronary events (myocardial infarction or unstable angina)
Measured: 2 years
Ischemic stroke
Ischemic stroke assessed at 2 years
Measured: 2 years
All-cause mortality
All-cause mortality assessed at 2 years
Measured: 2 years
Aortic events
Aortic events (aneurysm or dissection)
Measured: 2 years
Major vascular relapse
Major vascular relapse assessed at 2 years
Measured: 2 years
Lower limb revascularization
- Lower limb revascularization assessed at 2 years
Measured: 2 years
Anterior ischemic optic neuropathy (AION)
Anterior ischemic optic neuropathy (AION) assessed at 2 years
Measured: 2 years
Peripheral artery disease events
Peripheral artery disease events assessed at 2 years
Measured: 2 years
Cancer incidence
Cancer incidence at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jan 2012
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,667 participants (actual)
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
- NCT07459335
- Sponsor's protocol ID
- TACTIC-GCA-2026
- Acronym
- TACTIC-GCA
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.
PubMed 28756037Scailteux LM, Droitcourt C, Balusson F, Nowak E, Kerbrat S, Dupuy A, Drezen E, Happe A, Oger E. French administrative health care database (SNDS): The value of its enrichment. Therapie. 2019 Apr;74(2):215-223. doi: 10.1016/j.therap.2018.09.072. Epub 2018 Oct 25.
PubMed 30392702Hernan MA, Wang W, Leaf DE. Target Trial Emulation: A Framework for Causal Inference From Observational Data. JAMA. 2022 Dec 27;328(24):2446-2447. doi: 10.1001/jama.2022.21383.
PubMed 36508210Guedon AF, Espitia O, Beydon M, Ghrenassia E, Mirault T, Messas E, Tubach F, Seror R, Boccara F, Cohen A, Frikke-Schmidt R, Nordestgaard BG, Dellal A, Fain O, Mekinian A, Carrat F. Cardiovascular risk among Giant cells arteritis patients. Eur J Prev Cardiol. 2026 Jan 14:zwag034. doi: 10.1093/eurjpc/zwag034. Online ahead of print.
PubMed 41537566Guedon AF, Cacoub P, Carrat F, Espitia O, Mirouse A, Ghrenassia E, Fain O, Mekinian A, Saadoun D. Tocilizumab Is Associated With a Lower Incidence of Major Adverse Cardiovascular Events in Giant Cell Arteritis. Circulation. 2026 Aug 29. doi: 10.1161/CIRCULATIONAHA.126.080365. Online ahead of print.
PubMed 42667206
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Tocilizumab Versus Methotrexate on Major Adverse Cardiovascular Events in Giant Cell Arteritis: A Nationwide Target Trial Emulation Using the French SNDS
- ClinicalTrials.gov ID
- NCT07459335
- Acronym / sponsor ID
- TACTIC-GCA / TACTIC-GCA-2026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,667 participants (actual)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Mar 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.
This nationwide observational study emulates a target trial to compare the effect of tocilizumab versus methotrexate initiation on major adverse cardiovascular events (MACE) in patients with incident giant cell arteritis using the French National Health Data System (SNDS).
Detailed description
Study Design and Data Source This study is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. We emulated a hypothetical randomized trial comparing two treatment strategies: initiation of tocilizumab versus methotrexate within 6 months after hospital discharge for incident giant cell arteritis. Eligible patients aged ≥50 years hospitalized for incident GCA between 2012 and 2024 were included.
Statistical Analysis A clone-censor-weight approach was used to account for treatment initiation timing and avoid immortal time bias. Inverse probability of censoring weights were applied to adjust for informative censoring. Treatment effects were estimated using weighted Kaplan-Meier methods and Cox proportional hazards models.
Outcomes The primary outcome was the occurrence of major adverse cardiovascular events (MACE), defined as myocardial infarction, ischemic stroke, or all-cause death. Secondary outcomes included individual cardiovascular components, aortic events, and major vascular relapse.
Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab group | – | –Patients initiating tocilizumab within 6 months after discharge for incident GCA. |
| Methotrexate group | – | –Patients initiating methotrexate within 6 months after discharge for incident GCA. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥50 years hospitalized for incident giant cell arteritis in France identified from the SNDS database.
Key inclusion criteria (1 listed)
- Age ≥50 years Incident hospitalization for giant cell arteritis Initiation of tocilizumab or methotrexate within 6 months Received systemic corticosteroids ≥20 mg/day within 30 days following hospital discharge
Key exclusion criteria (1 listed)
- Prior use of tocilizumab or methotrexate Age >90 years Length of stay >30 days Not discharged home Prior aortic disease or vascular imaging within 2 years Initiation of both treatments during grace period
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
Major Adverse Cardiovascular Events (MACE)
Time frame: 2 years
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
9 secondary outcomes
Coronary events
Time frame: 2 years
Ischemic stroke
Time frame: 2 years
All-cause mortality
Time frame: 2 years
Aortic events
Time frame: 2 years
Major vascular relapse
Time frame: 2 years
Lower limb revascularization
Time frame: 2 years
Anterior ischemic optic neuropathy (AION)
Time frame: 2 years
Peripheral artery disease events
Time frame: 2 years
Cancer incidence
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publication: PubMed 28756037Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.
- Results publication: PubMed 30392702Scailteux LM, Droitcourt C, Balusson F, Nowak E, Kerbrat S, Dupuy A, Drezen E, Happe A, Oger E. French administrative health care database (SNDS): The value of its enrichment. Therapie. 2019 Apr;74(2):215-223. doi: 10.1016/j.therap.2018.09.072. Epub 2018 Oct 25.
- Results publication: PubMed 36508210Hernan MA, Wang W, Leaf DE. Target Trial Emulation: A Framework for Causal Inference From Observational Data. JAMA. 2022 Dec 27;328(24):2446-2447. doi: 10.1001/jama.2022.21383.
- Results publication: PubMed 41537566Guedon AF, Espitia O, Beydon M, Ghrenassia E, Mirault T, Messas E, Tubach F, Seror R, Boccara F, Cohen A, Frikke-Schmidt R, Nordestgaard BG, Dellal A, Fain O, Mekinian A, Carrat F. Cardiovascular risk among Giant cells arteritis patients. Eur J Prev Cardiol. 2026 Jan 14:zwag034. doi: 10.1093/eurjpc/zwag034. Online ahead of print.
- Derived from this study: PubMed 42667206Guedon AF, Cacoub P, Carrat F, Espitia O, Mirouse A, Ghrenassia E, Fain O, Mekinian A, Saadoun D. Tocilizumab Is Associated With a Lower Incidence of Major Adverse Cardiovascular Events in Giant Cell Arteritis. Circulation. 2026 Aug 29. doi: 10.1161/CIRCULATIONAHA.126.080365. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 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) and Cardiovascular Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 2 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 1 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: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07459335, which also lists 5 linked publications.
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 9 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.