Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female of ≥18 years of age
Written informed consent
Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
Disease duration of at least 6 months
SLEDAI-2K score ≥ 6 at screening
Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening
Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.
You may not be if
Increase in dosing of corticosteroids within 2 weeks prior to screening
Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
Change in dosing of immunosuppressants or corticosteroids during the screening period
