Biomarkers in Giant Cells Arteritis (BioACG)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Giant Cells Arteritis

Treatments: Device: Imaging; Other: Ophthalmologic examination; Behavioral: Clinical evaluation; Other: Paraclinical evaluation; Biological: Dosage of biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT02844023

38RC15.198

Details and patient eligibility

About

Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.

Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.

So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.

With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.

The main goal is to determine a new diagnosis marker for giant cells arteritis.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient suffering from giant cells arteritis.
• Inclusion while discovery of symptoms, or during relapse.

Exclusion criteria

• Healthy volunteer
• Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica.
• Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patient with giant gells arteritis

Other group

Description:

50 patients with giant gells arteritis

Treatment:

Device: Imaging

Other: Ophthalmologic examination

Behavioral: Clinical evaluation

Other: Paraclinical evaluation

Control patients

Other group

Description:

50 control patients : blood from French national blood service (EFS)

Treatment:

Biological: Dosage of biomarkers