Horton's DiseaseACG et TREGNCT02857192
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease
A study testing Blood samples in people with Horton's Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Horton's Disease
- What is being tested?
- Blood samples
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2015to 25 Mar 2019
- Phase
- Interventional
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- Patients who have provided written consent
- Patients with national health insurance cover
- Age > 50 years
- Patients with a diagnosis of Horton's disease, before any treatment
- Horton's disease is defined by the American College Rheumatology ACR criteria [2], as the association of 3 of the following 5 criteria:
Show all 17Show fewer
- age at disease onset 50 years or older
- recent onset localized headache
- indurated temporal artery or diminished/abolition of temporal pulse
- erythrocyte sedimentation rate (ESR) greater than 50 mm during the first hour (or C Reactive protein (CRP)>20 mg/L)
- Positive temporal artery biopsy (TAB) showing vascularitis with infiltration by mononuclear cells or granulomatous inflammation with or without giant cells.
- Control subjects
- Control subjects will be healthy volunteers recruited among blood donors at Dijon University Hospital, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious, inflammatory or auto-immune diseases or cancer (CRP<5mg/L) recruited in the investigating departments of Dijon Hospital. They will be matched for age and sex and must meet the following criteria:
- Age > 50 years
- Patients with national health insurance cover
- Signed written informed consent form
- Absence of an inflammatory syndrome (CRP<5 mg /L)
Who cannot join
- Adult under guardianship
- Persons without national health insurance cover
- Pregnant or breast-feeding women
- Patients treated with corticoids or immunosuppressants in the month preceding inclusion
- Patients treated with chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.
The study is classified interventional because a lot of blood samples are taken.
- Conditions
- Horton's Disease
- Being tested
- Blood samples
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| Horton | Experimental | Not described Receives: Biological: Blood samples |
| control | Placebo comparator | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL
Measured: through study completion an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start5 Oct 2015
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Horton's DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857192
- Sponsor's protocol ID
- SAMSON APJ 2014
- Acronym
- ACG et TREG
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Samson M, Greigert H, Ciudad M, Gerard C, Ghesquiere T, Trad M, Corbera-Bellalta M, Genet C, Ouandji S, Cladiere C, Thebault M, Ly KH, Liozon E, Maurier F, Bienvenu B, Terrier B, Guillevin L, Charles P, Quipourt V, Devilliers H, Gabrielle PH, Creuzot-Garcher C, Tarris G, Martin L, Saas P, Audia S, Cid MC, Bonnotte B. Improvement of Treg immune response after treatment with tocilizumab in giant cell arteritis. Clin Transl Immunology. 2021 Sep 12;10(9):e1332. doi: 10.1002/cti2.1332. eCollection 2021.
PubMed 34532040Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.
PubMed 32866179
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
- ClinicalTrials.gov ID
- NCT02857192
- Acronym / sponsor ID
- ACG et TREG / SAMSON APJ 2014
- Conditions
- Horton's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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 the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.
The study is classified interventional because a lot of blood samples are taken.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horton | Experimental | Biological: Blood samples |
| control | Placebo comparator | Biological: Blood samples |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients
- Patients who have provided written consent
- Patients with national health insurance cover
- Age > 50 years
- Patients with a diagnosis of Horton's disease, before any treatment
Key exclusion criteria (5 listed)
- Adult under guardianship
- Persons without national health insurance cover
- Pregnant or breast-feeding women
- Patients treated with corticoids or immunosuppressants in the month preceding inclusion
- Patients treated with chemotherapy
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 |
|---|---|---|
| Blood samples | Biological | Horton, control |
Primary outcome
Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL
Time frame: through study completion an average of 30 months
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 6 Feb 2026.
- Results publication: PubMed 34532040Samson M, Greigert H, Ciudad M, Gerard C, Ghesquiere T, Trad M, Corbera-Bellalta M, Genet C, Ouandji S, Cladiere C, Thebault M, Ly KH, Liozon E, Maurier F, Bienvenu B, Terrier B, Guillevin L, Charles P, Quipourt V, Devilliers H, Gabrielle PH, Creuzot-Garcher C, Tarris G, Martin L, Saas P, Audia S, Cid MC, Bonnotte B. Improvement of Treg immune response after treatment with tocilizumab in giant cell arteritis. Clin Transl Immunology. 2021 Sep 12;10(9):e1332. doi: 10.1002/cti2.1332. eCollection 2021.
- Derived from this study: PubMed 32866179Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Horton's Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 17 inclusion and 5 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 6 Feb 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 France. 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. Some participants in this study may receive a placebo. 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?
Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL (time frame: through study completion an average of 30 months). 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 NCT02857192, which also lists 2 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 6 Feb 2026.