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Hydroxychloroquine in Giant Cell Arteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430807
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : October 6, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: hydroxychloroquine/placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
Study Start Date : January 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  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 Outcome Measures :
  1. prednisone daily dosage [ Time Frame: 6, 12, 18 and 24 months ]
  2. hydroxychloroquine blood levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430807

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Agen, France, 47923
Albi, France, 81000
Hospital Auch
Auch, France, 32008
Hospital Avignon
Avignon, France, 84902
University Hospital Besançon
Besançon, France, 25030
Hospital Béziers
Beziers, France, 34525
University Hospital Côte de Nacre
Caen, France, 14033
University Hospital Dijon
Dijon, France, 21035
Foix, France, 09017
Lavaur, France, 81500
University Hospital Dupuytren
Limoges, France, 87042
Lisieux, France, 14100
Lourdes, France, 65107
Mazamet, France, 81200
Montauban, France, 82013
University Hospital
Nantes, France, 44035
Saint Louis Hospital
Paris, France, 75010
University Hospital Saint Antoine
Paris, France, 75012
University Hospital Bichat
Paris, France, 75018
Hospital Suresnes
Suresnes, France, 92151
University Hospital Toulouse
Toulouse, France, 31059
University Hospital
Toulouse, France, 31059
University Hospital Bretonneau
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: ARLET Philippe, D CHU Toulouse, Hôpital Purpan
Study Director: SAILLER Laurent, MD CHU Toulouse, Service de Médecine Interne, Hôpital Purpan

Additional Information:

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Responsible Party: University Hospital, Toulouse Identifier: NCT00430807     History of Changes
Other Study ID Numbers: 0102808
PHRC 2001 ( Other Grant/Funding Number: Ministry of Health )
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Keywords provided by University Hospital, Toulouse:
giant cell arteritis,
corticosteroid sparing,
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents