Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
- Study ID
- NCT05394909
- Status
- Completed
Conditions
- GCA
- Glucocorticoids
- PET
- TOCILIZUMAB
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab 162Mg/0.9Ml Autoinjector — DRUGPatients 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
Study Details
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.
Key Dates
- Start date
- Feb 7, 2020
- Status verified
- May 2022
- Primary completion
- Feb 25, 2022
- Completion
- Oct 20, 2022
Study Design
- Enrollment
- 20 participants (actual)
Primary Outcome Measure
Change from baseline at 24, 52 and 76 weeks variation of MRA grading of large vessel vasculitis [ Time Frame: Baseline, 24, 52, 76 weeks ]