Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
With
Merck KGaA, Darmstadt, Germany
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female 16 years of age or older
Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
You may not be if
Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
Previous treatment with rituximab, abatacept, or belimumab
History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
Clareo Health | Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
