Hydroxychloroquine in Giant Cell Arteritis

Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430807

Enrollment

Registered

2007-02-02

Start date

2002-01-31

Completion date

2006-12-31

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

giant cell arteritis,, hydroxychloroquine,, corticosteroid sparing,, corticodependence

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.

Interventions

DRUGhydroxychloroquine/placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
prednisone daily dosage	6, 12, 18 and 24 months
hydroxychloroquine blood levels	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026