A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

Study Overview
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Brief Summary
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This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.

Official Title
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A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: TNF inhibitor/TCZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria. Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors). The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment. Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent. Exclusion Criteria: Have had more than one TNF-inhibitor prior to the enrolment visit. Have had biological treatment other than TNF-inhibitors. Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).

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 |
| --- | --- |
| RA participants treated with a TNF inhibitor or TCZ<br>Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed. | Drug: TNF inhibitor/TCZ<br>* Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.<br>* Other names: COTTON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with a decrease in dose of oral corticosteroids during the study |  | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving C59CDAI remission (</=2.8) |  | From baseline to 6 months | 
| Percentage of participants achieving CDAI LDA (</=10) |  | From baseline to 6 months | 
| Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period |  | Baseline, Month 6 | 
| Percentage of participants for whom non-biologic DMARDs was added during observation period |  | From baseline to 6 months | 
| Percentage of participants with dose change in biological treatment during study |  | From baseline to 6 months | 
| Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study |  | From baseline to 6 months | 
| Percentage of participants who started or stopped oral corticosteroid treatment during the study period |  | From baseline to 6 months | 
| Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study |  | From baseline to 6 months | 
| Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline |  | From baseline to 6 months | 
| Cumulated doses of oral corticosteroids during study period |  | From baseline to 6 months | 
| Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections |  | From baseline to 6 months | 
| Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections |  | From baseline to 6 months | 
| Cumulated doses of all corticosteroids during study period |  | From baseline to 6 months | 
| Mean dose of corticosteroids at start and end of study |  | From baseline to 6 months | 
| Mean change from baseline to end of study of corticosteroids |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in crohns disease activity index (CDAI) score |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in swollen 28 joint count |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in tender 28 joint count |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale) |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale) |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI) |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in Severity of pain (VAS scale) |  | Baseline, Month 6 | 
| Mean change from baseline to end of study in EULAR response |  | Baseline, Month 6 | 
| Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6) |  | From baseline to 6 months | 
| Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2) |  | From baseline to 6 months |