A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.
Inclusion Criteria:
Exclusion Criteria:
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Ciudad Autonoma Buenos Aires, C1426AAL, Argentina
Mainz, Rhineland-Palatinate 55131, Germany
Morelia, Michoacán 58249, Mexico
Mérida, Yucatán 97130, Mexico
Angeles City, Pampanga, 2009, Philippines
Moscow, 119992, Russia
Seoul, Gyeonggi-do 110744, South Korea