A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

Study Overview
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Brief Summary
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This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.

Official Title
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A Multicenter, Prospective, Observational, Non-Interventional Study Evaluating the Efficacy and Safety of Using Tocilizumab (TCZ) for Confirmed Rheumatoid Arthritis (RA) Patients In Clinical Practice

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with moderate-to-severe active rheumatoid arthritis (RA) for over 3 months Started on tocilizumab, with or without previous history of biological treatment Exclusion Criteria: Pregnant or lactating women Treated with an investigational drug within 30 days prior to initiation of study drug Having a condition that, in the opinion of the investigator, could compromise the participant's safety or interfere with the study results

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 confirmed rheumatoid arthritis<br> | Other: No intervention<br>* No intervention administered in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24 |  | Week 24 | 
| Number of Participants with Adverse Events |  | Up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Percentage of Participants with DAS28 < 2.6 at Week 12 |  | Week 12 | 
| Mean Change in DAS28 |  | Baseline, Week 12, and Week 24 | 
| Mean Change in CDAI |  | Baseline, Week 12, and Week 24 | 
| Mean Change in TJC |  | Baseline and Week 24 | 
| Mean Change in SJC |  | Baseline and Week 24 | 
| Mean Change in CRP |  | Baseline and Week 24 | 
| Mean Change in PGH |  | Baseline and Week 24 |