Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Study Overview
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Brief Summary
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This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

Official Title
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Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants at least 18 years old Participants with moderate to severe RA not previously treated with TCZ (Intravenous [IV] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) Exclusion Criteria: Participants taking part in a clinical trial on RA at the time of inclusion Participants with a contra-indication to TCZ SC therapy

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 Moderate to Severe RA<br>Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included. | Drug: Methotrexate<br>* Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.<br>Drug: Tocilizumab<br>* Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were on TCZ SC for a Period of 12 Months |  | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP) |  | Months 3, 6, 12, and 18 | 
| Simple Disease Activity Index (SDAI) |  | Months 3, 6, 12, and 18 | 
| Clinical Disease Activity Index (CDAI) |  | Months 3, 6, 12, and 18 | 
| Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response |  | Months 3, 6, 12, and 18 | 
| Percentage of Participants Who Were on TCZ SC for a Period of 6 Months |  | Up to 6 Months | 
| Percentage of Participants Who Were on TCZ SC for a Period of 18 Months |  | Up to 18 Months | 
| Percentage of Participants who were on TCZ SC at 6, 12 and 18 Months Among 2 Subgroups: Participants Administered TCZ SC as Monotherapy and Participants Administered TCZ SC with Methotrexate or csDMARD |  | Up to 18 Months | 
| Dose of Concomitant Steroids After Introduction of TCZ SC |  | Months 6, 12, and 18 | 
| Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data |  | Months 6, 12, and 18 | 
| Percentage of Participants with Definitive Discontinuation of Treatment |  | Up to 18 Months | 
| Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist |  | Up to 18 Months | 
| Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA |  | Up to 18 Months | 
| Tender Joints Count |  | Months 3, 6, 12, and 18 | 
| Swollen Joints Count |  | Months 3, 6, 12, and 18 | 
| Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) |  | Months 3, 6, 12, and 18 |