The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.
Study Type
OBSERVATIONAL
Enrollment
102
Tocilizumab will be given according to summary of product characteristics as per clinical practice.
Unnamed facility
Bydgoszcz, Poland
Unnamed facility
Bydgoszcz, Poland
Unnamed facility
Bytom, Poland
Unnamed facility
Gmina Śrem, Poland
Unnamed facility
Krakow, Poland
Unnamed facility
Krakow, Poland
Unnamed facility
Lublin, Poland
Unnamed facility
Olsztyn, Poland
Unnamed facility
Poznan, Poland
Unnamed facility
Sieradz, Poland
...and 5 more locations
Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
Time frame: Month 6
Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment
Time frame: Month 6
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Time frame: Baseline up to Month 6
Time to Discontinuation
Time frame: Baseline up to Month 6
Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate
Time frame: Baseline up to Month 6
Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline
Time frame: Baseline
Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment
Time frame: Month 3
Change From Baseline in DAS28 Over Time
Time frame: Baseline up to Month 6
Change From Baseline in C-Reactive Protein (CRP) Over Time
Time frame: Baseline up to Month 6
Percentage of Participants With Discontinuations Due to Lack of Efficacy
Time frame: Baseline up to Month 6
Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)
Time frame: Baseline up to Month 6
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