Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients, between 18 and 75 years of age, inclusive.
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
Autoantibody-positive.
On active and stable SLE disease.
B cell subsets expressed as percentage of total B cells above normal.
You may not be if
Pregnant and nursing.
Have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, which ever is longer.
Have received intravenous or oral cyclophosphamide within 180 days of Day 0.
Severe active lupus nephritis or chronic renal insufficiency.
Active or chronic, severe neuropsychiatric lupus.
Acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection.
Have current drug or alcohol abuse or dependence.
Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
