GCATOPAZIONCT05394909
Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients
An observational study of GCA and TOCILIZUMAB, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GCA, TOCILIZUMAB, Glucocorticoids
- What is being tested?
- Tocilizumab 162Mg/0.9Ml Autoinjector
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2020to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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
- Previous treatment with tocilizumab or any other biological agent within last 6 months before screening visit; Rituximab within 12 months before screening visit
- Treatment with any investigational agent within 28 days of screening visit or 5 half-lives of the investigational drug (whichever is the longer)
- History of severe allergic or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of tocilizumab
- Receipt of any vaccine within 28 days prior to screening visit (a patient's vaccination record and need for immunization prior to receiving tocilizumab/placebo must be carefully investigated)
- Positive tests for hepatitis B surface antigen (HBsAg) or hepatitis C serology
- Positive Quantiferon-TB® test for latent Tb without subsequent INH prophylaxis
- Patients with active Tb which had to be treated for Tb within 2 years before the screening visit
- Absolute neutrophil count (ANC) < 2.0 x 103/µL, white blood cells < 2.5 x 103/µL, platelet count < 100,000/ µL
- Hemoglobin < 8.0 g/dL
- Concentrations of serum IgG and/or IgM below 5.0 mg/mL and 0.40 mg/mL, respectively
- Serum creatinine > 2.0 mg/dL (200 µmol/L)
- Alanine aminotransferase (ALT) or aspartate amino-transferase (AST) > 1.5 times the upper limit of normal (ULN)
- Total bilirubin > 1.5 times the upper limit of normal (ULN)
- Triglycerides > 400 mmol/dL (non-fasted) or > 250 mmol/dL (fasted) at screening
- Premenopausal status and nursing (definition of postmenopausal status: Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child-bearing potential)
- Technical implants such as cardiac pacemakers (for MR-angiogram)
- Claustrophobia (for MR-angiogram)
- Known allergy against the contrast media (Multihance® or Dotarem® as alternative)
- Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ausl-Irccs - S.C. Di Reumatologia
Reggio Emilia, Emilia-Romagna, 42123
About this study
Official title: Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study
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.
Read the detailed description
- 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).
- Duration of study per Subject 52 weeks of observation during standard of care (SOC) and 24 weeks of follow-up
- 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)
- 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.
- 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
- Being tested
- Tocilizumab 162Mg/0.9Ml Autoinjector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab 162Mg/0.9Ml AutoinjectorDrug
Also called methylprednisolone pulse 500 MG
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, 24, 52, 76 weeks
Secondary outcomes (2)
Variation of Aortic diameter at each time point
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.
Measured: 24, 52, and 76 weeks
Changes of concentrations of various cytokines in plasma and PBMC culture supernatants at each time point
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).
Measured: Baseline, 3 days, 24, 52 and 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start7 Feb 2020
- Primary completion25 Feb 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GCAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- carlo salvarani, MD, Principal investigator, AUSL-IRCCS REGGIO EMILIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394909
- Sponsor's protocol ID
- 186/2019/OSS
- Acronym
- TOPAZIO
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40650989Muratore 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.
PubMed 39150490Muratore 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.
PubMed 37195423
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study
- ClinicalTrials.gov ID
- NCT05394909
- Acronym / sponsor ID
- TOPAZIO / 186/2019/OSS
- Conditions
- GCA, TOCILIZUMAB, Glucocorticoids, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- Duration of study per Subject 52 weeks of observation during standard of care (SOC) and 24 weeks of follow-up
- 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)
- 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.
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab 162Mg/0.9Ml AutoinjectorAlso: methylprednisolone pulse 500 MGPatients 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 | Drug | – |
Primary outcome
Change from baseline at 24, 52 and 76 weeks variation of MRA grading of large vessel vasculitis
Time frame: Baseline, 24, 52, 76 weeks
To evaluate the morphological imaging (MRA scores) variations
Change from baseline at 24, 52 and 76 weeks variation of PET Vascular Activity Score (PETVAS)
Time frame: Baseline, 24, 52, 76 weeks
To evaluate the functional imaging (PET scores) variations
Change from baseline at 24, 52 and 76 weeks of the proportion of patients with relapse-free remission
Time frame: 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
2 secondary outcomes
Variation of Aortic diameter at each time point
Time frame: 24, 52, and 76 weeks
Changes of concentrations of various cytokines in plasma and PBMC culture supernatants at each time point
Time frame: Baseline, 3 days, 24, 52 and 76 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 40650989Durmo 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.
- Derived from this study: PubMed 39150490Muratore 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.
- Derived from this study: PubMed 37195423Muratore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
carlo salvarani, MD principal investigator
AUSL-IRCCS REGGIO EMILIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GCA and TOCILIZUMAB, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394909, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.