Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.

Official Title
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Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)

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: Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate Exclusion Criteria: Treatment with tocilizumab more than 8 weeks prior to enrollment Failure to meet local tocilizumab label indication criteria Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy History of any other autoimmune or joint inflammatory disease

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 |
| --- | --- |
| Tocilizumab for RA in Routine Clinical Practice<br>Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation. | Drug: Tocilizumab<br>* Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.<br>* Other names: RoActemra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study |  | Baseline, end of study (up to 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study |  | Baseline, end of study (up to 24 weeks) | 
| Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6 |  | Up to 24 weeks | 
| Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8 |  | Up to 24 weeks | 
| Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Baseline, end of study (up to 24 weeks) | 
| Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6 | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks | 
| Number of Tocilizumab SC Injections per Participant During Observational Treatment Period |  | Up to 24 weeks | 
| Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations |  | Up to 24 weeks | 
| Percentage of Participants on SC Tocilizumab First Line Monotherapy |  | Up to 24 weeks | 
| Percentage of Participants with Reasons for SC Tocilizumab Monotherapy |  | Up to 24 weeks | 
| Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week) |  | Up to 24 weeks | 
| Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period |  | Baseline, Week 24 | 
| Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study |  | Baseline, Week 24 | 
| Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period |  | Week 24 | 
| Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks | 
| Percentage of Participants with Adverse Events |  | Up to 24 weeks |