A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
研究单位:[1]AbbVie[2]First Affiliated Hospital of Kunming Medical University /ID# 164637 Kunming,China,650032[3]Parana Medical Research Center /ID# 153507 Maringa,Parana,Brazil,87015-000[4]LMK Sevicos Medicos S/S /ID# 152963 Porto Alegre,Rio Grande Do Sul,Brazil,90480-000[5]Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961 Sao Jose Do Rio Preto,Sao Paulo,Brazil,15090-000[6]CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966 São Paulo,Sao Paulo,Brazil,04266-010[7]1st Aff Hosp of Bengbu Med Col /ID# 162161 Bengbu,Anhui,China,233099[8]Anhui Provincial Hospital /ID# 161117 Hefei,Anhui,China,230001[9]Zhongshan Hosp. of Fudan Uni. /ID# 161108 Shanghai,Anhui,China,200032[10]The 1st Aff Hosp Xiamen Univ /ID# 162154 Xiamen,Fujian,China,361003
研究目的:
The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.
The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.