The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Sanofi-Synthelabo
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.