Hydroxychloroquine in Giant Cell Arteritis

Phase 3

Completed

• Conditions: Giant Cell Arteritis

• Registration Number: NCT00430807
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2005-01
• Study Completion: 2006-12
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-04
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
prednisone dosage equal to or lower than 5 mg since more than 3 months without	3 months at least
having experienced relapse since the inclusion in the study

Secondary Outcome Measures

Name	Time	Method
prednisone daily dosage	6, 12, 18 and 24 months
hydroxychloroquine blood levels

Trial Locations

Locations (15)

University Hospital Côte de Nacre; 🇫🇷 Caen, France

Hospital; 🇫🇷 Montauban, France

University Hospital Dijon; 🇫🇷 Dijon, France

University Hospital Bichat; 🇫🇷 Paris, France

University Hospital; 🇫🇷 Toulouse, France

Saint Louis Hospital; 🇫🇷 Paris, France

University Hospital Saint Antoine; 🇫🇷 Paris, France

University Hospital Dupuytren; 🇫🇷 Limoges, France

Hospital Auch; 🇫🇷 Auch, France

Hospital Avignon; 🇫🇷 Avignon, France

Hospital Suresnes; 🇫🇷 Suresnes, France

Hospital Béziers; 🇫🇷 Beziers, France

University Hospital Besançon; 🇫🇷 Besançon, France

University Hospital Toulouse; 🇫🇷 Toulouse, France

University Hospital Bretonneau; 🇫🇷 Tours, France