Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients
- Conditions
- PETTOCILIZUMABGCAGlucocorticoids
- Registration Number
- NCT05394909
- Lead Sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline at 24, 52 and 76 weeks variation of PET Vascular Activity Score (PETVAS) Baseline, 24, 52, 76 weeks To evaluate the functional imaging (PET scores) variations
Change from baseline at 24, 52 and 76 weeks variation of MRA grading of large vessel vasculitis Baseline, 24, 52, 76 weeks To evaluate the morphological imaging (MRA scores) variations
Change from baseline at 24, 52 and 76 weeks of the proportion of patients with relapse-free remission Baseline, 24, 52, 76 weeks Remission will be defined as the absence of any clinical symptoms directly attributable to vasculitis with normalization of CRP/ESR and absence of new/worsened vascular damage at MRA and/or CT
- Secondary Outcome Measures
Name Time Method Changes of concentrations of various cytokines in plasma and PBMC culture supernatants at each time point Baseline, 3 days, 24, 52 and 76 weeks The levels of various cytokines in plasma samples and PBMC culture supernatants will be analyzed following activation with anti-CD3 / CD28 beads and lipolysaccharide (LPS).
Variation of Aortic diameter at each time point 24, 52, and 76 weeks Aortic dilatation will be defined by a diameter\>40 mm in the ascending aorta, \>40 mm in the thoracic descending aorta and \>30 mm in the abdominal aorta. Any change of ≥5mm on serial CT will be considered significant aortic dilatation and significant progression of vascular damage.
Trial Locations
- Locations (1)
Ausl-Irccs - S.C. Di Reumatologia
🇮🇹Reggio Emilia, Emilia Romagna, Italy