Biomarkers in Giant Cells Arteritis

Not Applicable

Terminated

• Conditions: Giant Cells Arteritis
• Interventions: Behavioral: Clinical evaluation; Biological: Dosage of biomarkers; Other: Paraclinical evaluation; Device: Imaging; Other: Ophthalmologic examination

• Registration Number: NCT02844023
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-26
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with giant gells arteritis	Clinical evaluation	50 patients with giant gells arteritis
Patient with giant gells arteritis	Paraclinical evaluation	50 patients with giant gells arteritis
Patient with giant gells arteritis	Imaging	50 patients with giant gells arteritis
Patient with giant gells arteritis	Ophthalmologic examination	50 patients with giant gells arteritis
Control patients	Dosage of biomarkers	50 control patients : blood from French national blood service (EFS)

Primary Outcome Measures

Name	Time	Method
Biomarkers's serum sampling	3 minutes	For dosage of biomarkers in serum, like serum amyloid A or interleukins.

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France