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Study of T Lymphocytes in Patients With Horton Disease (GAMAIT)

This study is not yet open for participant recruitment.
Verified October 2017 by Centre Hospitalier Universitaire Dijon
Sponsor:
ClinicalTrials.gov Identifier:
NCT03313102
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose

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 [1].

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 [2] and which produce IL-17 and IFN-γ [3], two key cytokines in the pathophysiology of GCA [4-6] 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


Condition Intervention
Horton Disease Biological: blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of T Lymphocytes in the Mucosa in Giant-cell Arteritis (GCA) - Giant Cell Arteritis and Mucosal Associated Invariant T Cells

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry [ Time Frame: at inclusion ]

Secondary Outcome Measures:
  • Measure the percentage of blood MAIT (CD3+TCRγδ-CD4-Vα7.2+CD161+) among total TL (CD3+) by flow cytometry [ Time Frame: at 3 months ]

Estimated Enrollment: 60
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Horton disease Biological: blood samples
sample of 16 blood tubes
Experimental: control Biological: blood samples
sample of 16 blood tubes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 TAB showing vasculitis with infiltration of mononuclear cells or granulomatous inflammation with or without giant cells.

HEALTHY SUBJECTS Control 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 diseasee, or cancere or auto-immune disease (CRP<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy.

Exclusion Criteria:

  • Adults under guardianship
  • Pregnant or breast-feeding women
  • Patients who have been treated with corticosteroids or immunosuppressantsin the month preceding inclusion
  • Patients treated with chemotherapy, immunosuppressants or biotherapy
  • Contra-indication for corticosteroid therapy
  • Weight <41 kg or Hg <7g/l
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313102


Contacts
Contact: Maxime SAMSON, MD 3.80.29.34.32 ext +33 maxime.samson@chu-dijon.fr

Locations
France
CHU Dijon Bourgogne Not yet recruiting
Dijon, France, 21079
Contact: Maxime SAMSON, MD    3 80 29 34 32 ext +33    maxime.samson@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03313102     History of Changes
Other Study ID Numbers: Samson APJ 2016
First Submitted: October 13, 2017
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vasculitis, Central Nervous System
Vasculitis
Giant Cell Arteritis
Polymyalgia Rheumatica
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases