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Not yet recruitingNCT07720804GIDEONUpdated Jul 22, 2026

Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study (GIDEON)

An interventional study of Blood tests to measure CRP in Giant Cell Arteritis (GCA), sponsored by University Hospital, Limoges. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

We propose to analyze the kinetics of the main marker of inflammation in GCA in order to understand its links with initial clinical manifestations and the possible appearance of complications and/or relapses.

Early assessment of the rate of CRP normalization would enable us to adapt the therapeutic strategy in order to avoid complications and/or relapses.

Read the detailed description

Giant cell arteritis (GCA) is a chronic systemic vasculitis of the large vessels characterized by a significant inflammatory syndrome, correlated with disease activity and various inflammatory biomarkers, including CRP, which more effectively reflects disease activity.

Relapses remain frequent, with rates of up to 45.7%. Recommended treatments involve long-term corticosteroid therapy and/or sparing therapies, which are associated with adverse events.

Identifying relapsing patients is therefore crucial, in order to best adapt initial treatment and patient follow-up.

We therefore propose to study CRP kinetics at diagnosis and at initiation of corticosteroid therapy, to determine the link with disease progression.

02

Conditions studied

  • Giant Cell Arteritis (GCA)

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03

In context

Giant Cell Arteritis

147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.

This study's planned enrollment of 40 is below the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 18 or older hospitalized in the internal medicine department with a new diagnosis of ACG
  • Personne affiliée ou bénéficiaire d'un régime de sécurité sociale
  • Free and signed by the participant and the investigator

Exclusion criteria

Exclusion Criteria:

  • Patients scheduled to be placed on a sparing regimen during hospitalization
  • Patients with renal insufficiency ( ≤ 60 mL/min/1.73 m²)
  • Patients with a history of -treated pseudopolyarthritis
  • Patients with ACG and visual impairment (severity criterion)
  • Patients on or biologic therapy
  • infection or progressive
  • Known poor treatment adherence
  • Dementia
  • Pregnant or breastfeeding women
  • Patients under legal guardianship
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Patient with de novo diagnosis of GCA

    Blood samples for CRP determination

    Diagnostic Test: Blood tests to measure CRP

Interventions

  • Diagnostic testBlood tests to measure CRP

    Blood tests to measure CRP levels

06

What researchers measure

Primary outcomes

  1. CRP testing

    1. Immediately before starting corticosteroids 2. Every day immediately before taking the morning dose of corticosteroids, for 5 days, and up to 7 days if levels do not return to normal 3. Then once a week for up to 1 month after starting corticosteroids 4. Then monthly for 8 months during follow-up visits 5. Then every 2 months for up to 1 year

    Time frame: 1 year

Secondary outcomes

  1. Determining Corticosteroid Dosages and Estimating Their Half-Lives

    Corticosteroid Dosage: Take daily, just before your morning dose of corticosteroids

    Time frame: 5 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jun 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jul 22, 2026
StartEst.
Jun 22, 2026
Primary completionEst.
Jun 22, 2029
CompletionEst.
Jun 22, 2030
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07720804
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Jun 22, 2026 (estimated)
Primary completion
Jun 22, 2029 (estimated)
Completion
Jun 22, 2030 (estimated)
Last update
Jul 22, 2026

Study contacts

Kim LY, Professor
Contact
Kim.Ly@chu-limoges.fr
05 55 05 05 05

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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