Hydroxychloroquine in Giant Cell Arteritis

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00430807
First received: January 31, 2007
Last updated: July 23, 2009
Last verified: June 2008
  Purpose

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
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
  • having experienced relapse since the inclusion in the study

Secondary Outcome Measures:
  • prednisone dialy dosage at 6, 12, 18 and 24 months, hydroxychloroquine blood levels, number of relapses during follow-up, influence of HLA genotype on outcome.

Enrollment: 75
Study Start Date: January 2002
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430807

Locations
France
Hospital
Agen, France, 47923
Hospital
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
Hospital
Foix, France, 09017
Hospital
Lavaur, France, 81500
University Hospital Dupuytren
Limoges, France, 87042
Hospital
Lisieux, France, 14100
Hospital
Lourdes, France, 65107
Hospital
Mazamet, France, 81200
Hospital
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, France, 31059
University Hospital Toulouse
Toulouse, France, 31059
University Hospital Bretonneau
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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:
Publications:

ClinicalTrials.gov Identifier: NCT00430807     History of Changes
Other Study ID Numbers: 0102808, PHRC 2001
Study First Received: January 31, 2007
Last Updated: July 23, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Arteritis
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
Vasculitis, Central Nervous System
Hydroxychloroquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014