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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of RA Participants | Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab will be given according to summary of product characteristics as per clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment | Month 6 | |
| Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Baseline up to Month 6 | |
| Time to Discontinuation | Baseline up to Month 6 | |
| Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Participants with a diagnosis of moderate to severe RA who are inadequate responders to DMARDs, or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bydgoszcz | 85-168 | Poland | ||||
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| Baseline up to Month 6 |
| Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline | Baseline |
| Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment | Month 3 |
| Change From Baseline in DAS28 Over Time | Baseline up to Month 6 |
| Change From Baseline in C-Reactive Protein (CRP) Over Time | Baseline up to Month 6 |
| Percentage of Participants With Discontinuations Due to Lack of Efficacy | Baseline up to Month 6 |
| Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs) | Baseline up to Month 6 |
| Bydgoszcz |
| 85-681 |
| Poland |
| Bytom | 41-902 | Poland |
| Gmina Śrem | 63-100 | Poland |
| Krakow | 30-119 | Poland |
| Krakow | Poland |
| Lublin | 20-954 | Poland |
| Olsztyn | 10-045 | Poland |
| Poznan | 61-285 | Poland |
| Sieradz | 98-200 | Poland |
| Sopot | 81-759 | Poland |
| Starachowice | 27-200 | Poland |
| Sucha Beskidzka | 34-200 | Poland |
| Ustroń | 43-450 | Poland |
| Wroclaw | 50-981 | Poland |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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