Biomarkers in Giant Cells Arteritis

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StatusPrekinuta

Sponzori

University Hospital, Grenoble

KLINIČKIM ISPITIVANJIMA: NCT02844023

BioSeek: NCT02844023

Ključne riječi

Sažetak

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.

Datumi

Posljednja provjera:	03/31/2019
Prvo podneseno:	07/19/2016
Predviđena prijava predata:	07/21/2016
Prvo objavljeno:	07/25/2016
Zadnje ažuriranje poslato:	04/15/2019
Posljednje ažuriranje objavljeno:	04/17/2019
Stvarni datum početka studija:	12/31/2014
Procijenjeni datum primarnog završetka:	01/13/2019
Predviđeni datum završetka studije:	01/13/2019

Stanje ili bolest

Giant Cells Arteritis

Intervencija / liječenje

Behavioral: Patient with giant gells arteritis

Other: Patient with giant gells arteritis

Device: Patient with giant gells arteritis

Other: Patient with giant gells arteritis

Biological: Control patients

Faza

Grupe ruku

Arm	Intervencija / liječenje
Other: Patient with giant gells arteritis 50 patients with giant gells arteritis	Behavioral: Patient with giant gells arteritis With questionnaire.
Other: Control patients 50 control patients : blood from French national blood service (EFS)	Biological: Control patients Control patients.

Kriteriji prihvatljivosti

Polovi podobni za studiranje

All

Prihvaća zdrave volontere

Kriterijumi

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)

Ishod

Primarne mjere ishoda

1. Biomarkers's serum sampling [3 minutes]

For dosage of biomarkers in serum, like serum amyloid A or interleukins.

Biomarkers in Giant Cells Arteritis

Ključne riječi

glavobolja

upala

atrofija

giant cell arteritis

hyperesthesia

arteritis

vasculitis

antimikotično