NCT05394909

Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients

Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The objective of our study is to evaluate the functional and morphological imaging variations at 24 and 52 weeks compared to baseline during TCZ-treatment and 6 months after the suspension of TCZ. We will also evaluate the variations of aortic dilatation during the study period using the PET/CT in comparison with an hystorical cohort of patients with LVV treated with GCs only and longitudinally followed at our rheumatology division.

Detailed description

1. Trial Design Monocentric observational study, single arm, based on imaging of patients with active Large Vessel Giant Cell Arteritis (LV-GCA) , treated with Tocilizumab (TCZ) s.c. and with ultra-short glucocorticosteroids (GCs). 2. Duration of study per Subject 52 weeks of observation during standard of care (SOC) and 24 weeks of follow-up 3. Target Population Patients aged older than 50 years with active large vessel giant cell arteritis (LV-GCA) based on evidence of large vasculitis at imaging. Patients with active disease will be enrolled according to the following inclusion criteria: * PET/CT showing vascular FDG uptake ≥2 in at least one vascular district and at least one among * ESR \>40 mm/h or CRP \>10 mg/l * Cranial or systemic symptoms of GCA or symptoms of polymyalgia rheumatica (PMR) 4. Primary Objectives * To evaluate the functional and morphological imaging (PET and MRA scores) variations at 24, 52 and 76 weeks compared to baseline values. * To evaluate the proportion of patients with relapse free remission (RFR) at week 24, 52 and 76. * To assess agreement between of MRA and PET scores and physician-determined disease activity status. 5. Secondary Objectives * To evaluate if patients have a reduced risk of aortic dilatation compared with an hystorical cohort of patients with LVV treated with GCs only and longitudinally followed at our rheumatology division. * immunological effects of steroid and TCZ at baseline, after 3 days, at week 24, 52 and 76

Conditions

• GCA
• TOCILIZUMAB
• Glucocorticoids
• PET

Interventions

Type	Name	Description
DRUG	Tocilizumab 162Mg/0.9Ml Autoinjector	Patients will receive high-dose pulse intravenous methylprednisolone (500 mg ) for 3 consecutive days (Day 0-1-2) and subsequently will be treated weekly with Tocilizumab 162 mg s.c. for 52-weeks and then following according to SOC

Timeline

• Start date: 2020-02-07
• Primary completion: 2022-02-25
• Completion: 2022-10-20
• First posted: 2022-05-27
• Last updated: 2025-06-12

Locations

1 site across 1 country: Italy