This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with an inadequate response to non-biologic DMARDs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
162 mg will be administered once weekly by subcutaneous injection.
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
C. A. B. A., Argentina
Unnamed facility
Córdoba, Argentina
Unnamed facility
Rosario, Argentina
Unnamed facility
Goiânia, Goiás, Brazil
Unnamed facility
Cuiabá, Mato Grosso, Brazil
Unnamed facility
Juiz de Fora, Minas Gerais, Brazil
Unnamed facility
Rio de Janeiro, Rio de Janeiro, Brazil
...and 15 more locations
Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate
Time frame: 24 weeks
Safety: Incidence of adverse events (AE)
Time frame: 60 weeks
Efficacy: Change in DAS28-ESR
Time frame: From baseline to Week 52
Efficacy: ACR/EULAR responses
Time frame: 52 weeks
Efficacy: Change in disease activity (CDAI/SDAI)
Time frame: From baseline to Week 52
Efficacy: Change in joint swelling/tenderness (SJC/TJC)
Time frame: From baseline to Week 52
Safety: Assessment of immunogenicity
Time frame: 60 weeks
Patient-reported outcomes
Time frame: 60 weeks
Efficacy: DAS28-ESR Remission Rate
Time frame: 52 weeks
Efficacy: Proportion of patients who maintain DAS28 Remission/LDA
Time frame: From Week 24 to Week 52
Safety: Rates of AE leading to dose modification or study withdrawal
Time frame: 52 weeks
Safety: Assessment of physical examination and vital signs
Time frame: 52 weeks
Safety: Incidence of clinically significant laboratory abnormalities following treatment
Time frame: 52 weeks
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