- Male or female subjects between ages of 18 and 75 years old at time of signing
consent.
- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American
College of Rheumatology (ACR) criteria.
- Have a unequivocally positive anti-nuclear antibody (ANA) test result.
- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to
6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or
central nervous system) or BILAG B disease in more than or equal to 2 organ systems if
no level A disease in present.
- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
- Have received any of the following within 364 days of day 1: a biologic
investigational agent other than B cell targeted therapy; required 3 or more courses
of systemic corticosteroids for concomitant conditions; history of previously
untreated or current evidence of active or untreated latent infection with
Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
radiography, residing with or frequent close contact with an individual with active
TB.