This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe rheumatoid arthritis who completed the WA19926 core study. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
8 mg/kg iv every 4 weeks, up to 104 weeks
Unnamed facility
Skopje, North Macedonia
Long-term safety: Incidence of adverse events
Time frame: approximately 3 years
Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)
Time frame: from baseline to Week 104
Change in total tender joint count (TJC) / swollen joint count (SJC)
Time frame: from baseline to Week 104
Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit
Time frame: approximately 3 years
Time to rheumatoid arthritis flare in patients who have entered drug-free remission
Time frame: approximately 3 years
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