Study of T Lymphocytes in Patients With Horton Disease

NCT03313102 | Unknown

• 1 other identifier: Samson APJ 2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid therapy is the reference treatment for GCA. This treatment is highly effective but must be maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse effects in this elderly population. Currently clinicians have no way to estimate this risk of relapse during the treatment of GCA. Invariant T lymphocytes associated with the mucous membrane (MAIT), whose role in vasculitides has recently been shown and which produce IL-17 and IFN-γ, two key cytokines in the pathophysiology of GCA could be implicated in the pathophysiology of GCA and could constitute a predictive marker of relapse. Our hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and that the number of circulating MAIT in the blood falls and then returns to normal if the corticoids are effective. Given that it will be necessary to include a large number of patients to show that the persistence of a low number of circulating MAIT in patients treated with corticoids is a predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain preliminary data on these new markers. The study is classified as interventional because a lot of blood samples are taken

Conditions

Horton Disease

Outcome Measures

Primary Outcomes (1)

• Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry

  at inclusion

Secondary Outcomes (1)

• Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry

  at 3 months

Study Arms (2)

Horton disease

EXPERIMENTAL

Biological: blood samples

control

EXPERIMENTAL

Biological: blood samples

Interventions

blood samples BIOLOGICAL

sample of 16 blood tubes

Horton disease; control

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENTS
• Patients who have provided written consent
• Patients with national health insurance cover
• Age \> 50 years
• Patients with Horton disease at the diagnosis, before any treatment.
• Horton disease is defined by ACR criteria \[7\], the diagnosis is made in the presence of 3 of the following 5 criteria:
• Age at the onset of the disease of 50 years or older
• Recent-onset localized headache
• Temporal artery tenderness or decreased temporal artery pulse
• Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP\>20 mg/L)
• Positive temporal artery biopsy (TAB) showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells.
• Control groups:
• Control Group 1: Healthy subjects Healthy subjects will be matched for age and sex with patients. They will be recruited in Dijon only. They will be healthy volunteers recruited among blood donors, voluntary hospital personnel (nurses, doctors and secretaries) and patients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP\<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy.
• Control Group 2: (PPR without ACG)
• Patient with oral consent

You may not qualify if:

• Adults under guardianship
• Pregnant or breast-feeding women
• Patients treated with chemotherapy, immunosuppressants or biotherapy
• Contra-indication for corticosteroid therapy
• Weight \<41 kg or Hg \<7g/l

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Maxime SAMSON, MD

CONTACT

3.80.29.34.32; maxime.samson@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: November 16, 2017
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

FR (1)