Hydroxychloroquine in Giant Cell Arteritis

Toulouse University Hospital

Status and phase

Completed

Phase 3

Conditions

Giant Cell Arteritis

Treatments

Drug: hydroxychloroquine/placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00430807

0102808

PHRC 2001

Details and patient eligibility

About

Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.

Enrollment

75 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
corticosteroid treatment since less than 1 month
age less than 85 years
signed informed consent

Exclusion criteria

amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
low life expectancy (<2 years)
corticosteroid treatment since more than 30 days whatever the dosage
primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
previous psychiatric troubles induced corticosteroids
hydroxychloroquine contra-indicated