A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)

Study Overview
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Brief Summary
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This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Official Title
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A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ)

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit. Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed Exclusion Criteria: Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra History of autoimmune disease or any joint inflammatory disease other than 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 |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on RoActemra/Actemra at 6 months |  | approximately 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of dose modifications/interruptions |  | approximately 20 months | 
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment |  | approximately 20 months | 
| Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR |  | approximately 20 months | 
| Physician Global Assessment of disease activity |  | approximately 20 months | 
| Patient reported outcomes: Health Assessment Questionnaires |  | approximately 20 months | 
| Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) |  | approximately 20 months | 
| Time to reduction/withdrawal of corticosteroids |  | approximately 20 months | 
| Safety: Incidence of adverse events\n |  | approximately 20 months |