Aneurysm Clinical Trial
Official title:
Efficacy and Safety of Tocilizumab and Tofacitinib in the Treatment of Patients With Vascular Behçet's Syndrome
This project aims to evaluate the efficacy and safety of the combination of glucocorticoids with tocilizumab or tofacitinib, compared to the traditional combination of glucocorticoids with cyclophosphamide in the treatment of vascular Behçet's syndrome.
Behçet's Syndrome (BS) is a recurrent and systemic vasculitis, with an incidence rate of about 14/100,000 in China, higher than that in Europe and America. Vascular Behcet's Syndrome (VBS) is an important subtype of BS characterized by multiple venous and artery lesions. It affects 20-25% of BS patients, predominantly young adult males, and is the leading cause of mortality in BS patients (67%), especially in patients with aneurysms. Therefore, exploring the diagnosis and treatment strategies for VBS is key to improving the prognosis of BS. This project aims to investigate the efficacy and safety of the combination of glucocorticoids (GCS) with the biologic agent tocilizumab or the targeted small molecule tofacitinib, compared to the combination of GCS with cyclophosphamide in the treatment of VBS aneurysms, as well as to screen for biomarkers related to the response of tocilizumab or tofacitinib, and to improve the assessment and treatment of VBS and establish a precision diagnosis and treatment strategy. This is a Phase IIb, multi-center, randomized, open-label, GCS plus cyclophosphamide-controlled, parallel design, prospective clinical study. Patients will be randomly assigned to three groups in a 1:1:1 ratio (tocilizumab + GCS vs tofacitinib + GCS vs cyclophosphamide + GCS, 27:27:27) after screening and recruitment. Patients will be followed up every 4 weeks from weeks 0-12, and every 6 weeks from weeks 12-24. The primary endpoint is the complete remission (CR) rate at the 12th-week follow-up. All participants will undergo their final visit at 24 weeks. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06235619 -
Arch Size Study for Anatomical Variations
|
||
| Not yet recruiting |
NCT00905931 -
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
|
Phase 2 | |
| Completed |
NCT01178710 -
Effect of Simvastatin on Cardiac Function
|
N/A | |
| Completed |
NCT00349908 -
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
|
Phase 1 | |
| Recruiting |
NCT03285100 -
The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation
|
N/A | |
| Recruiting |
NCT06189950 -
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE
|
N/A | |
| Active, not recruiting |
NCT04592185 -
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
|
||
| Completed |
NCT01970605 -
Silver Graft All Comers Registry
|
||
| Completed |
NCT00282893 -
Balloon Prophylaxis of Aneurysmal Vasospasm
|
Phase 2 | |
| Active, not recruiting |
NCT00549380 -
Clinical Study of Aneurysm Exclusion
|
Phase 1 | |
| Completed |
NCT04598802 -
COvera in BRAnch Registry
|
||
| Completed |
NCT04246125 -
Patient Skin Dose in Interventional Radiology
|
||
| Recruiting |
NCT05829746 -
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS
|
N/A | |
| Completed |
NCT03242343 -
VasQ External Support for Arteriovenous Fistula
|
N/A | |
| Recruiting |
NCT02878967 -
Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm
|
||
| Active, not recruiting |
NCT02345005 -
Iliac Branch Excluder ReGistry (IceBERG)
|
||
| Recruiting |
NCT02167997 -
EffectiveNess and SAfety of Small ANeurysm COiling Trial
|
N/A | |
| Recruiting |
NCT00549016 -
Clinical Study of Aneurysm Exclusion
|
N/A | |
| Completed |
NCT02848612 -
Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
|
||
| Enrolling by invitation |
NCT04269447 -
Prospective Aortic Biobank of POP-STAR
|