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NCT Number: NCT00430807

Hydroxychloroquine in Giant Cell Arteritis

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.

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydroxychloroquine/placebo

Drug

Primary outcomes

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

    Time frame: 3 months at least

  2. having experienced relapse since the inclusion in the study

Secondary outcomes

  1. prednisone daily dosage

    Time frame: 6, 12, 18 and 24 months

  2. hydroxychloroquine blood levels

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Feb 2, 2007
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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