Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00413361
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00413361
Study Brief:
Protocol Section:
NCT00413361