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)
Study Identifier
M15-557
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Chinese (China), Korean, Portuguese (Brazil)
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
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.
Study Locations
Location
Status
Location
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964
Curitiba, Paraná, Brazil, 80030-110
Status
Not applicable
Location
Parana Medical Research Center /ID# 153507
Maringá, Paraná, Brazil, 87015-000
Status
Not applicable
Location
LMK Sevicos Medicos S/S /ID# 152963
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
Status
Not applicable
Location
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961
São José do Rio Preto, São Paulo, Brazil, 15090-000
Status
Not applicable
Location
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 152966
São Paulo, São Paulo, Brazil, 04266-010
Status
Not applicable
Location
1st Aff Hosp of Bengbu Med Col /ID# 162161
Bengbu, Anhui, China, 233099
Status
Not applicable
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