Horton's DiseaseHorton CD8NCT02158208
Study of the T CD8 Immune Response in Horton's Disease
An observational study of Horton's Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease. At the inclusion visit, patients will have, as is the case in the usual strategy: A complete clinical examination carried out by the doctor in charge of the patient ESR, and CRP and fibrinogen assay A full blood… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Horton's Disease
- What is being tested?
- Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment, 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment and Blood sample drawn into a 5 mL dry tube
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2013to 25 Jan 2016
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting Horton's disease at the diagnosis before any treatment
Who may be able to join
- Patients
- Patients who have provided written informed consent
- Patients covered by national health insurance
- Age > 50 years
- Patients with Horton's disease at the diagnosis before any treatment
- Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:
Show all 16Show fewer
- age at the onset of the disease 50 years or above
- recent onset localised headache
- indurated temporal artery or decrease/absence of temporal pulse
- erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP>20 mg/L)
- positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.
- Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.
- Age > 50 years
- Patients covered by national health insurance
- who have provided written informed consent to take part
- Absence of inflammatory syndrome (CRP<5 mg /L)
Who cannot join
- Any patient not meeting inclusion criteria
- Patient 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
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.
At the inclusion visit, patients will have, as is the case in the usual strategy:
Read more
- A complete clinical examination carried out by the doctor in charge of the patient
- ESR, and CRP and fibrinogen assay
- A full blood count for leukocytes and lymphocytes
- A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.
In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:
- Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
- A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
- 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.
- Conditions
- Horton's Disease
- Being tested
- Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment, 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment, Blood sample drawn into a 5 mL dry tube, 16 blood samples drawn into 6 mL heparinized tubes
- Keywords
- before any treatment, at the diagnosis
- 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 sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatmentOther
16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatmentOther
Blood sample drawn into a 5 mL dry tubeOther
16 blood samples drawn into 6 mL heparinized tubesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with HD | Not described Receives: Other: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment; Other: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment | |
| Controls | Not described Receives: Other: Blood sample drawn into a 5 mL dry tube; Other: 16 blood samples drawn into 6 mL heparinized tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)
Measured: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start25 Jul 2013
- Primary completion25 Jan 2016
- Study completion25 Jan 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT02158208
- Sponsor's protocol ID
- SAMSON APJ 2013
- Acronym
- Horton CD8
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2014
- Last updated
- 12 Mar 2026
- Results posted
- No
Publications
Samson M, Ly KH, Tournier B, Janikashvili N, Trad M, Ciudad M, Gautheron A, Devilliers H, Quipourt V, Maurier F, Meaux-Ruault N, Magy-Bertrand N, Manckoundia P, Ornetti P, Maillefert JF, Besancenot JF, Ferrand C, Mesturoux L, Labrousse F, Fauchais AL, Saas P, Martin L, Audia S, Bonnotte B. Involvement and prognosis value of CD8(+) T cells in giant cell arteritis. J Autoimmun. 2016 Aug;72:73-83. doi: 10.1016/j.jaut.2016.05.008. Epub 2016 May 25.
PubMed 27236507Maldiney 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the T CD8 Immune Response in Horton's Disease
- ClinicalTrials.gov ID
- NCT02158208
- Acronym / sponsor ID
- Horton CD8 / SAMSON APJ 2013
- Conditions
- Horton's Disease
- Keywords
- before any treatment, at the diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Jul 2013 (actual)
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 6 Jun 2014 (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.
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.
At the inclusion visit, patients will have, as is the case in the usual strategy:
- A complete clinical examination carried out by the doctor in charge of the patient
- ESR, and CRP and fibrinogen assay
- A full blood count for leukocytes and lymphocytes
- A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.
In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:
- Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
- A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
- 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with HD | – | Other: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment, Other: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment |
| Controls | – | Other: Blood sample drawn into a 5 mL dry tube, Other: 16 blood samples drawn into 6 mL heparinized tubes |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting Horton's disease at the diagnosis before any treatment
Key inclusion criteria (16 listed)
- Patients
- Patients who have provided written informed consent
- Patients covered by national health insurance
- Age > 50 years
- Patients with Horton's disease at the diagnosis before any treatment
Key exclusion criteria (3 listed)
- Any patient not meeting inclusion criteria
- Patient 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 sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment | Other | Patients with HD |
| 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment | Other | Patients with HD |
| Blood sample drawn into a 5 mL dry tube | Other | Controls |
| 16 blood samples drawn into 6 mL heparinized tubes | Other | Controls |
Primary outcome
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)
Time frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment
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 Mar 2026.
- Results publication: PubMed 27236507Samson M, Ly KH, Tournier B, Janikashvili N, Trad M, Ciudad M, Gautheron A, Devilliers H, Quipourt V, Maurier F, Meaux-Ruault N, Magy-Bertrand N, Manckoundia P, Ornetti P, Maillefert JF, Besancenot JF, Ferrand C, Mesturoux L, Labrousse F, Fauchais AL, Saas P, Martin L, Audia S, Bonnotte B. Involvement and prognosis value of CD8(+) T cells in giant cell arteritis. J Autoimmun. 2016 Aug;72:73-83. doi: 10.1016/j.jaut.2016.05.008. Epub 2016 May 25.
- 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.
Related trials for Horton's Disease
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Clonal Hematopoiesis in Giant Cell Arteritis
Giant Cell Arteritis, Temporal Arteritis
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?
An observational study of 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 16 inclusion and 3 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 Mar 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. 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?
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+) (time frame: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment). 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 NCT02158208, 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 12 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.