Clinical Trial: Hydroxychloroquine in Giant Cell Arteritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
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.
Detailed Summary:
Sponsor: University Hospital, Toulouse
Current Primary Outcome:
- prednisone dosage equal to or lower than 5 mg since more than 3 months without [ Time Frame: 3 months at least ]
- having experienced relapse since the inclusion in the study
Original Primary Outcome:
- prednisone dosage equal to or lower than 5 mg since more than 3 months without
- having experienced relapse since the inclusion in the study
Current Secondary Outcome:
- prednisone daily dosage [ Time Frame: 6, 12, 18 and 24 months ]
- hydroxychloroquine blood levels
Original Secondary Outcome: 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.
Information By: University Hospital, Toulouse
Dates:
Date Received: January 31, 2007
Date Started: January 2002
Date Completion:
Last Updated: October 4, 2015
Last Verified: October 2015
