Status:
COMPLETED
The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml
Detailed Description
Hydroxychloroquine (HCQ) is a treatment which allows preventing Systemic Lupus Erythematosus (SLE) exacerbations. HCQ can be measured in whole-blood by HPLC (High Performance Liquid Chromatography). ...
Eligibility Criteria
Inclusion
- Age of 18 and above
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria.
- Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months
- Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day)
- No increase in the steroids dosage during the 3 previous weeks
- Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent
- No modifications of a possible immunosuppressor during the 2 previous months
- SELENA-SLEDAI \< or = 12
- Signature of the consent of participation
Exclusion
- Known retinopathy, present or passed
- Severe cataract obstructing the ophthalmologic monitoring
- MONOPHTALM patients
- Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage
- Use of nivaquine during the 3 previous months
- Treatment with biotherapy (for example Rituximab) during the 12 previous months
- Calculated clearance of creatinin lower than 60 ml/min
- Chronic alcoholism
- Liver failure
- Desire of pregnancy in the next 7 months
- Known non compliance, and risks of random follow-up
- Absence of social security cover
- People profiting from a particular protection:
- Pregnant women
- Age under 18
- Patient under supervision and TRUSTEESHIP
- People who are hospitalized without their consent and not protected by the law
- People who are private of freedom.
- Criteria of inclusion at the visit of randomization (D0):
- All the patients responding to the next criterions can be randomized:
- Blood HCQ concentration ranging between 100 and 750 ng/ml at the time of the visit of preselection,
- No increase in the steroids dosage since last visit
- No modifications of a possible immunosuppressor since last visit
- SELENA-SLEDAI \< or = 12 Activity of the lupus remaining stable (no increase of more than 2 points of the SELENA-SLEDAI),
- Ophthalmologic examination in the 6 previous months with no contra-indication for the use of HCQ,
- Absences of conductive disorders on the ECG
- Use of an effective contraception,
- Negative Beta-HCG.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT00413361
Start Date
June 1 2007
End Date
January 1 2011
Last Update
January 27 2011
Active Locations (2)
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1
Chu Pitie Salpetriere
Paris, France, 75013
2
Hopital la Pitié Salpétrière Assistance Publique
Paris, France, 75013