Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients

NCT05394909 | Completed

• 1 other identifier: 186/2019/OSS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

GCA; TOCILIZUMAB; Glucocorticoids; PET

Outcome Measures

Primary Outcomes (3)

• Change from baseline at 24, 52 and 76 weeks variation of MRA grading of large vessel vasculitis

  To evaluate the morphological imaging (MRA scores) variations

  Baseline, 24, 52, 76 weeks

• Change from baseline at 24, 52 and 76 weeks variation of PET Vascular Activity Score (PETVAS)

  To evaluate the functional imaging (PET scores) variations

  Baseline, 24, 52, 76 weeks

• Change from baseline at 24, 52 and 76 weeks of the proportion of patients with relapse-free remission

  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

  Baseline, 24, 52, 76 weeks

Secondary Outcomes (2)

• Variation of Aortic diameter at each time point

  24, 52, and 76 weeks

• Changes of concentrations of various cytokines in plasma and PBMC culture supernatants at each time point

  Baseline, 3 days, 24, 52 and 76 weeks

Interventions

Tocilizumab 162Mg/0.9Ml Autoinjector DRUG

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

Also known as: methylprednisolone pulse 500 MG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be focused on patients aged older than 50 years with active large vessel giant cell arteritis (LV-GCA) based on evidence of large vessel vasculitis (LVV) at imaging.

You may qualify if:

• Patients aged older than 50 years with large vessel giant cell arteritis (LV-GCA)
• PET/CT showing vascular FDG uptake ≥2 in at least one vascular district
• ESR \>40 mm/h or CRP \>10 mg/l OR Cranial or systemic symptoms of GCA or symptoms of polymyalgia rheumatica (PMR)
• Patient's written informed consent.

You may not qualify if:

• Use of more than 10 mg/day of prednisone (or equivalent) for more than 10 consecutive days in the previous three months
• Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA or polymyalgia rheumatica (i.e., RA, autoimmune connectivitides, other systemic vasculitides, a.o.)
• Chronic use of systemic CS with inability, in the opinion of the investigator, to withdraw CS treatment at day 4 according to protocol
• Evidence of significant and/or uncontrolled concomitant disease such as, but not limited to, cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine (in particular diabetes mellitus) or gastrointestinal disorders (including previous complicated diverticulitis) which, in the investigator's opinion, would preclude patient participation or impact the benefit-risk ratio
• History of amaurosis fugax,visual loss or diplopia
• Any condition or general state of health which, in the Investigator's opinion, would preclude participation in the study
• Actual or recent myocardial infarction (within the last 3 months before screening visit)
• Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive pulmonary disease (COPD) (FEV1 \< 50% predicted or Functional dyspnea \> Grade 3 on the MRC Dyspnea Scale) or other significant pulmonary disease
• Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where flares are commonly treated with oral or injectable corticosteroids
• Known active infection of any kind, or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks before screening visit
• History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks before screening visit
• Any surgical procedure, including bone/joint surgery within 8 weeks prior before screening visit or planned within the duration of the study
• History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks before screening visit
• Lack of peripheral venous access
• Body weight \> 150 kg or BMI \> 35

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Ausl-Irccs - S.C. Di Reumatologia

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Related Publications (3)

• Durmo R, Muratore F, Marvisi C, Cassone G, Ricordi C, Boiardi L, Mancuso P, Besutti G, Spaggiari L, Casali M, Croci S, Di Tommaso G, Leoni F, Fioroni F, Catanoso M, Giorgi Rossi P, Salvarani C, Versari A. Exploring total inflammatory vascular volume as a diagnostic and prognostic biomarker in giant cell arteritis. Rheumatology (Oxford). 2025 Nov 1;64(11):5863-5871. doi: 10.1093/rheumatology/keaf381.

  PMID: 40650989 DERIVED

• Muratore F, Marvisi C, Cassone G, Ricordi C, Boiardi L, Mancuso P, Besutti G, Spaggiari L, Casali M, Croci S, Durmo R, Versari A, Di Tommaso G, Catanoso M, Giorgi Rossi P, Salvarani C. Treatment of giant cell arteritis with ultra-short glucocorticoids and tocilizumab: results from the extension of the TOPAZIO study. Rheumatology (Oxford). 2025 May 1;64(5):3057-3062. doi: 10.1093/rheumatology/keae400.

  PMID: 39150490 DERIVED

• Muratore F, Marvisi C, Cassone G, Boiardi L, Mancuso P, Besutti G, Spaggiari L, Casali M, Croci S, Versari A, Giorgi Rossi P, Catanoso M, Costantini M, Galli E, Salvarani C. Treatment of giant cell arteritis with ultra-short glucocorticoids and tocilizumab: the role of imaging in a prospective observational study. Rheumatology (Oxford). 2024 Jan 4;63(1):64-71. doi: 10.1093/rheumatology/kead215.

  PMID: 37195423 DERIVED

MeSH Terms

Interventions

tocilizumab

Study Officials

• carlo salvarani, MD

  AUSL-IRCCS REGGIO EMILIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 27, 2022
• Study Start: February 7, 2020
• Primary Completion: February 25, 2022
• Study Completion: October 20, 2022
• Last Updated: June 12, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)