EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.

Official Title
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Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment. Exclusion Criteria: Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment. Participants who have received TCZ in past treatments. Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC. Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).

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 |
| --- | --- |
| Subcutaneous Tocilizumab<br>Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label. | Biological: Tocilizumab<br>* Subcutaneous Tocilizumab according to approved label.<br>* Other names: ACTEMRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation |  | At 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Assessment Questionnaire (HAQ) Score |  | At baseline, 24 and 52 weeks | 
| Visual Analog Scale (VAS) Pain Score in a 100 mm Scale |  | At baseline, 24 and 52 weeks | 
| Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale |  | At baseline, 24 and 52 weeks | 
| Percentage of Participants with Clinically Significant Changes in Laboratory Values |  | At baseline, 24 and 52 weeks | 
| Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy |  | At baseline, 24 and 52 weeks | 
| Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs) |  | At baseline, 24 and 52 weeks | 
| Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs) |  | Up to 52 weeks | 
| Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs |  | Up to 52 weeks | 
| Percentage of Participants with IEs with Laboratory Abnormalities |  | Up to 52 weeks | 
| Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs |  | Up to 52 weeks | 
| Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs |  | Up to 52 weeks | 
| Percentage of Participants on Glucocorticoids (GCs) with AEs |  | Up to 52 weeks | 
| Disease Activity Score 28 (DAS28) |  | At baseline, 24 and 52 weeks | 
| Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR) |  | At baseline, 24 and 52 weeks |