Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:37 PM
Study NCT ID:
NCT07459335
Status:
COMPLETED
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TArget Trial Emulation Comparing Effectiveness of Tocilizumab vs Methotrexate In Corticosteroid-Treated GCA Patients
Sponsor:
Groupe français d'étude des Maladies Inflammatoires de loeil
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACTIC-GCA
Brief 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).
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: