Hydroxychloroquine in Giant Cell Arteritis

October 4, 2015 updated by: University Hospital, Toulouse

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Hospital
      • Albi, France, 81000
        • Hospital
      • Auch, France, 32008
        • Hospital Auch
      • Avignon, France, 84902
        • Hospital Avignon
      • Besançon, France, 25030
        • University Hospital Besancon
      • Beziers, France, 34525
        • Hospital Beziers
      • Caen, France, 14033
        • University Hospital Côte de Nacre
      • Dijon, France, 21035
        • University Hospital Dijon
      • Foix, France, 09017
        • Hospital
      • Lavaur, France, 81500
        • Hospital
      • Limoges, France, 87042
        • University Hospital Dupuytren
      • Lisieux, France, 14100
        • Hospital
      • Lourdes, France, 65107
        • Hospital
      • Mazamet, France, 81200
        • Hospital
      • Montauban, France, 82013
        • Hospital
      • Nantes, France, 44035
        • University Hospital
      • Paris, France, 75010
        • Saint Louis hospital
      • Paris, France, 75012
        • University Hospital Saint Antoine
      • Paris, France, 75018
        • University Hospital Bichat
      • Suresnes, France, 92151
        • Hospital Suresnes
      • Toulouse, France, 31059
        • University Hospital Toulouse
      • Toulouse, France, 31059
        • University Hospital
      • Tours, France, 37044
        • University Hospital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prednisone dosage equal to or lower than 5 mg since more than 3 months without
Time Frame: 3 months at least
3 months at least
having experienced relapse since the inclusion in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
prednisone daily dosage
Time Frame: 6, 12, 18 and 24 months
6, 12, 18 and 24 months
hydroxychloroquine blood levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 4, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102808
  • PHRC 2001 (Other Grant/Funding Number: Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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