The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00413361
• Date of registration: 18/12/2006
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS
• Scientific title: Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study
• Date of first enrolment: June 2007
• Target sample size: 543
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00413361
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Nathalie COSTEDOAT-CHALUMEAU, MD,
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: versus hydroxychloroquine

Primary Outcome(s)

The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period. [Time Frame: 7 months of follow up]

Secondary Outcome(s)

the mean change on the score of analogical visual scale in each group [Time Frame: 7 months of follow up]

The total number of flares in each group [Time Frame: 7 months of follow up]

the area under the curve of SELENA SLEDAI in each group [Time Frame: 7 months of follow up]

The number of patients in each group who developed a flare during the study period. [Time Frame: 7 months of follow up]

the mean change of the quality of life questionnaire SF-36 [Time Frame: 7 months of follow up]

the total dose of steroids in each group [Time Frame: 7 months of follow up]

Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening. [Time Frame: 7 months of follow up]

Secondary ID(s)

P051070

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi-Synthelabo