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
  • Rheumatoid Arthritis
  • Study Drug
  • Upadacitinib
  • Placebo
  • 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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