Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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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.

Official Title
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TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants at least 18 years of age a diagnosis of moderate to severe RA treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of DMARDs inadequate responders or participants who are intolerant to DMARDs) in a routine clinical practice in Poland informed consent Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of RA Participants<br>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. | Drug: Tocilizumab<br>* Tocilizumab will be given according to summary of product characteristics as per clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |