Giant Cell ArteritisSONIC-TIMENCT07508514
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
An observational study of Giant Cell Arteritis and Temporal Arteritis, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis, Temporal Arteritis, Optic Nerve Diseases
- What is being tested?
- Optic Nerve Sheath Ultrasound, Temporal artery ultrasound and Bloodwork : CRP and ESR
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Adult, Older adult
Study population: Eligible patients will consist of those who consult at our GCA fast-track clinic, have completed the SONIC-GCA baseline procedures, and have received a diagnosis of GCA on that visit.
Who may be able to join
- Participants must be enrolled in SONIC-GCA and must have:
- completed the baseline optic nerve sheath ultrasound
- confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA.
- Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.
- Ability and willingness to provide written informed consent.
- Agreement to complete the SONIC-TIME intensive follow-up schedule.
Who cannot join
- 1) Concurrent participation in a blinded interventional pharmaceutical clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Jean-Paul Makhzoum, MD, MSc, jean-paul.makhzoum@umontreal.ca
Guylaine Marcotte, guylaine.marcotte.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis
Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA.
The SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylprednisolone, and early use of steroid-sparing therapies.
Read more
Sixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy.
The primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.
- Being tested
- Optic Nerve Sheath Ultrasound, Temporal artery ultrasound, Bloodwork : CRP and ESR
- Medical subject headings
- Giant Cell Arteritis, Optic Nerve Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath UltrasoundDiagnostic test
Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.
Temporal artery ultrasoundDiagnostic test
With measurement of the intima-media complex and calculation of the OGUS.
Bloodwork : CRP and ESRDiagnostic test
At each visit
| Study group | Role | What they receive |
|---|---|---|
| GCA group | Patients with new-onset GCA who completed the SONIC-GCA (main study) baseline visit and who received 48 hours or less of glucocorticoids and less or equal to 160mg of oral prednisone equivalent.
Study visits : Baseline, then days 3, 7, 10, 14, 21, 28, and Month 2 Receives: Diagnostic Test: Optic Nerve Sheath Ultrasound; Diagnostic Test: Temporal artery ultrasound; Diagnostic Test: Bloodwork : CRP and ESR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean ONSD (in mm) from day 0 to day 28
To quantify the change in mean ONSD (in mm, by ultrasound) between baseline (Day 0) and Day 28 after GC initiation in patients with GCA exposed to ≤ 48 hours and ≤ 120 mg prednisone-equivalent before baseline.
Measured: Day 28
Secondary outcomes (10)
Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14
To quantify the change in mean ONSD between baseline (Day 0) and Day14 after GC initiation in patients with GCA exposed to ≤ 48 hours and ≤ 120 mg prednisone-equivalent before baseline.
Measured: Day 14
Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2
To model ONSD change over the first eight weeks using with time-updated cumulative GC exposure.
Measured: Month 2
Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound)
To determine the dose-response relationship between ONSD and cumulative GC exposure.
Measured: Month 2
Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound)
To evaluate the influence of IV methylprednisolone on ONSD evolution.
Measured: Month 2
Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound)
To assess the impact of early initiated steroid-sparing therapies initiated as standard of care on ONSD trajectory.
Measured: Month 2
ONSD threshold (from the SONIC-GCA trial) performance over time
To evaluate the time-adjusted ONSD performance based on the established SONIC-GCA ONSD cutoff.
Measured: Month 2
Time (in days) to ONSD normalization
To estimate the adjusted time to first attainment of an ONSD value below the established SONIC-GCA ONSD cutoff.
Measured: Month 2
Association between inflammatory markers and ONSD
To quantify correlations between ONSD and systemic inflammatory biomarkers over the early therapy period.
Measured: Month 2
Association between OGUS and ONSD
To examine associations between ONSD and the temporal artery ultrasound OGUS score over the early therapy period.
Measured: Month 2
Association between digital retinal fundoscopy and ONSD (in mm, by ultrasound)
To compare ONSD trajectories between participants with and without GCA-related retinal abnormalities on digital retinal fundoscopy.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 May 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Makhzoum, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Jean-Paul Makhzoum, MD, MSc, Study chair, CISSS du Nord-de-l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508514
- Sponsor's protocol ID
- 2026-3095
- Acronym
- SONIC-TIME
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT07508514
- Acronym / sponsor ID
- SONIC-TIME / 2026-3095
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 2 Apr 2026 (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.
Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA.
The SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylprednisolone, and early use of steroid-sparing therapies.
Sixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy.
The primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCA group | – | Diagnostic Test: Optic Nerve Sheath Ultrasound, Diagnostic Test: Temporal artery ultrasound, Diagnostic Test: Bloodwork : CRP and ESRPatients with new-onset GCA who completed the SONIC-GCA (main study) baseline visit and who received 48 hours or less of glucocorticoids and less or equal to 160mg of oral prednisone equivalent. Study visits : Baseline, then days 3, 7, 10, 14, 21, 28, and Month 2 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will consist of those who consult at our GCA fast-track clinic, have completed the SONIC-GCA baseline procedures, and have received a diagnosis of GCA on that visit.
Key inclusion criteria (6 listed)
- Participants must be enrolled in SONIC-GCA and must have:
- Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.
- Ability and willingness to provide written informed consent.
- Agreement to complete the SONIC-TIME intensive follow-up schedule.
Key exclusion criteria (1 listed)
- 1) Concurrent participation in a blinded interventional pharmaceutical clinical trial.
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 |
|---|---|---|
| Optic Nerve Sheath UltrasoundOptic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy. | Diagnostic test | GCA group |
| Temporal artery ultrasoundWith measurement of the intima-media complex and calculation of the OGUS. | Diagnostic test | GCA group |
| Bloodwork : CRP and ESRAt each visit | Diagnostic test | GCA group |
Primary outcome
Change in mean ONSD (in mm) from day 0 to day 28
Time frame: Day 28
To quantify the change in mean ONSD (in mm, by ultrasound) between baseline (Day 0) and Day 28 after GC initiation in patients with GCA exposed to ≤ 48 hours and ≤ 120 mg prednisone-equivalent before baseline.
10 secondary outcomes
Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14
Time frame: Day 14
Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2
Time frame: Month 2
Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound)
Time frame: Month 2
Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound)
Time frame: Month 2
Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound)
Time frame: Month 2
ONSD threshold (from the SONIC-GCA trial) performance over time
Time frame: Month 2
Time (in days) to ONSD normalization
Time frame: Month 2
Association between inflammatory markers and ONSD
Time frame: Month 2
Association between OGUS and ONSD
Time frame: Month 2
Association between digital retinal fundoscopy and ONSD (in mm, by ultrasound)
Time frame: Month 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Paul Makhzoum, MD, MSc study chair
CISSS du Nord-de-l'ile de Montreal
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 Giant Cell Arteritis and Temporal Arteritis, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul Makhzoum, MD, MSc (514-338-2222, jean-paul.makhzoum@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean ONSD (in mm) from day 0 to day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.