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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1667}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '2 years', 'description': 'Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death'}], 'secondaryOutcomes': [{'measure': 'Coronary events', 'timeFrame': '2 years', 'description': 'Coronary events (myocardial infarction or unstable angina)'}, {'measure': 'Ischemic stroke', 'timeFrame': '2 years', 'description': 'Ischemic stroke assessed at 2 years'}, {'measure': 'All-cause mortality', 'timeFrame': '2 years', 'description': 'All-cause mortality assessed at 2 years'}, {'measure': 'Aortic events', 'timeFrame': '2 years', 'description': 'Aortic events (aneurysm or dissection)'}, {'measure': 'Major vascular relapse', 'timeFrame': '2 years', 'description': 'Major vascular relapse assessed at 2 years'}, {'measure': 'Lower limb revascularization', 'timeFrame': '2 years', 'description': '7\\. Lower limb revascularization assessed at 2 years'}, {'measure': 'Anterior ischemic optic neuropathy (AION)', 'timeFrame': '2 years', 'description': 'Anterior ischemic optic neuropathy (AION) assessed at 2 years'}, {'measure': 'Peripheral artery disease events', 'timeFrame': '2 years', 'description': 'Peripheral artery disease events assessed at 2 years'}, {'measure': 'Cancer incidence', 'timeFrame': '2 years', 'description': 'Cancer incidence at 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Giant Cell Arteritis (GCA)', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '28756037', 'type': 'RESULT', 'citation': "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': '30392702', 'type': 'RESULT', 'citation': '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': '36508210', 'type': 'RESULT', 'citation': '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': '41537566', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nStatistical 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.\n\nOutcomes 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.\n\nRegulatory 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged ≥50 years hospitalized for incident giant cell arteritis in France identified from the SNDS database.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT07459335', 'acronym': 'TACTIC-GCA', 'briefTitle': 'TArget Trial Emulation Comparing Effectiveness of Tocilizumab vs Methotrexate In Corticosteroid-Treated GCA Patients', 'organization': {'class': 'OTHER', 'fullName': "Groupe français d'étude des Maladies Inflammatoires de loeil"}, 'officialTitle': 'Comparative Effect of Tocilizumab Versus Methotrexate on Major Adverse Cardiovascular Events in Giant Cell Arteritis: A Nationwide Target Trial Emulation Using the French SNDS', 'orgStudyIdInfo': {'id': 'TACTIC-GCA-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tocilizumab group', 'description': 'Patients initiating tocilizumab within 6 months after discharge for incident GCA.'}, {'label': 'Methotrexate group', 'description': 'Patients initiating methotrexate within 6 months after discharge for incident GCA.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'APHP_ Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'APHP_ Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe français d'étude des Maladies Inflammatoires de loeil", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}