Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice

Study Overview
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Brief Summary
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ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.

Official Title
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A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have not yet been treated with tocilizumab Participants who have received the first injection with tocilizumab maximum 1 month before inclusion in the study and the necessary baseline data and disease characteristics are present Exclusion Criteria: Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis

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 |
| --- | --- |
| Participants with Rheumatoid Arthritis<br>Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment |  | Up to Week 104 | 
| Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants |  | Up to Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Mean DAS28-ESR Score |  | Baseline up to Week 104 | 
| Percentage of Participants with Continuation of Tocilizumab |  | Up to Week 104 | 
| Mean Retention Time of Tocilizumab |  | Up to Week 104 | 
| Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment |  | From Baseline up to tocilizumab treatment discontinuation (Up to Week 104) | 
| Percentage of Participants with Concomitant Treatment with Methotrexate (MTX) |  | Up to Week 104 | 
| Percentage of Participants with Low Disease Activity Defined by DAS28-ESR |  | Up to Week 104 | 
| Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI) |  | Up to Week 104 | 
| Percentage of Participants with Low Disease Activity Defined by CDAI |  | Up to Week 104 | 
| Change from Baseline in Mean CDAI Score |  | Baseline up to Week 104 | 
| Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response |  | At Month 3 and Month 6 | 
| Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs) |  | Up to Week 104 | 
| Mean Dose Used for Concomitant GCs |  | Up to Week 104 | 
| Percentage of Participants with Dose Reduction for Concomitant GCs |  | Up to Week 104 | 
| Treatment Satisfaction Visual Analogue Scale (VAS) |  | Up to Week 104 | 
| Treatment User-Friendliness VAS |  | Up to Week 104 | 
| Percentage of Participants with Treatment Adherence |  | Up to Week 104 | 
| Response to Follow-up Treatment in Case of Switch from Tocilizumab |  | Up to Week 104 | 
| Percentage of Participants with Adverse Events During Follow-up Treatment |  | Up to Week 104 | 
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |  | Up to Week 104 | 
| Hannover Functional Ability Questionnaire (FFbH) Score |  | Up to Week 104 | 
| Percentage of Participants by Type of Physical Exercise |  | Up to Week 104 | 
| Percentage of Participants by Frequency of Physical Exercise |  | Up to Week 104 | 
| Percentage of Participants by Duration of Physical Exercise |  | Up to Week 104 | 
| Fatigue-VAS |  | Up to Week 104 | 
| Sleep Disturbance-VAS |  | Up to Week 104 | 
| State-Trait Anxiety Inventory (STAI) Questionnaire |  | Up to Week 104 | 
| Beck Depression Inventory (BDI) Questionnaire |  | Up to Week 104 | 
| Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) |  | Up to Week 104 |