NCT07459335

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

13 years

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Giant Cell Arteritis (GCA)Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death

    2 years

Secondary Outcomes (9)

  • Coronary events

    2 years

  • Ischemic stroke

    2 years

  • All-cause mortality

    2 years

  • Aortic events

    2 years

  • Major vascular relapse

    2 years

  • +4 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥50 years hospitalized for incident giant cell arteritis in France identified from the SNDS database.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHP_ Hôpital Saint-Antoine

Paris, 75012, France

Location

APHP_ Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (4)

  • 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.

    PMID: 28756037RESULT

  • Scailteux 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.

    PMID: 30392702RESULT

  • Hernan 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.

    PMID: 36508210RESULT

  • Guedon 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.

    PMID: 41537566RESULT

MeSH Terms

Conditions

Giant Cell ArteritisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

January 1, 2012

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)