Hydroxychloroquine in Giant Cell Arteritis

University Hospital, Toulouse75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Giant Cell Arteritis

Interventions

hydroxychloroquine/placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (23)

Hospital

Agen, France

Hospital

Albi, France

Outcomes

Primary Outcomes

prednisone dosage equal to or lower than 5 mg since more than 3 months without

Time frame: 3 months at least

having experienced relapse since the inclusion in the study

Secondary Outcomes

prednisone daily dosage

Time frame: 6, 12, 18 and 24 months

hydroxychloroquine blood levels

Data from ClinicalTrials.gov

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