Hydroxychloroquine in Giant Cell Arteritis

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
First received: January 31, 2007
Last updated: October 4, 2015
Last verified: October 2015
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 Intervention Phase
Giant Cell Arteritis
Drug: hydroxychloroquine/placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • prednisone dosage equal to or lower than 5 mg since more than 3 months without [ Time Frame: 3 months at least ] [ Designated as safety issue: No ]
  • having experienced relapse since the inclusion in the study [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prednisone daily dosage [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • hydroxychloroquine blood levels [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: January 2002
Study Completion Date: December 2006
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00430807

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
Principal Investigator: ARLET Philippe, D CHU Toulouse, Hôpital Purpan
Study Director: SAILLER Laurent, MD CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
  More Information

Additional Information:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00430807     History of Changes
Other Study ID Numbers: 0102808  PHRC 2001 
Study First Received: January 31, 2007
Last Updated: October 4, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
giant cell arteritis,
corticosteroid sparing,

Additional relevant MeSH terms:
Giant Cell Arteritis
Polymyalgia Rheumatica
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Connective Tissue Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Vascular
Vascular Diseases
Vasculitis, Central Nervous System
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2016