Hydroxychloroquine in Giant Cell Arteritis

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Hydroxychloroquine

Criteria

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