|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2015 |
|
Main ID: |
NCT00430807 |
|
Date of registration:
|
31/01/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Hydroxychloroquine in Giant Cell Arteritis
|
|
Scientific title:
|
Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis. |
|
Date of first enrolment:
|
January 2002 |
|
Target sample size:
|
75 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00430807 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
ARLET Philippe, D |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU Toulouse, Hôpital Purpan |
|
|
Name:
|
SAILLER Laurent, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU Toulouse, Service de Médecine Interne, Hôpital Purpan |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Giant Cell Arteritis
|
|
Intervention(s)
|
|
Drug: hydroxychloroquine/placebo
|
|
Primary Outcome(s)
|
|
having experienced relapse since the inclusion in the study
[Time Frame: No]
|
|
prednisone dosage equal to or lower than 5 mg since more than 3 months without
[Time Frame: 3 months at least]
|
|
Secondary Outcome(s)
|
|
prednisone daily dosage
[Time Frame: 6, 12, 18 and 24 months]
|
|
hydroxychloroquine blood levels
[Time Frame: No]
|
|
Secondary ID(s)
|
|
PHRC 2001
|
|
0102808
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|