Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

Study Overview
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Brief Summary
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This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

Official Title
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CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tocilizumab
* Drug: NSAIDs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV) Current users of NSAIDs due to RA as assessed by the physician Exclusion Criteria: Contraindications to treatment with tocilizumab as per SPC Prior therapy with tocilizumab

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 RA<br>Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use. | Drug: Tocilizumab<br>* Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.<br>* Other names: RoACTEMRA®;Drug: NSAIDs<br>* Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration |  | Day -14 to Day 0 (Baseline) | 
| Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration |  | 14 days after 6-8 weeks of tocilizumab administration | 
| Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration |  | 14 days after 12-16 weeks of tocilizumab administration | 
| Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration | NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (</=) 100%. | Day -14 to Day 0 (Baseline) | 
| Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration | NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%. | 14 days after 6-8 weeks of tocilizumab administration | 
| Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration | NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%. | 14 days after 12-16 weeks of tocilizumab administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Take NSAIDs |  | Day -14 up to approximately Day 126 | 
| Average Daily Dose of NSAIDs |  | Day -14 up to approximately Day 126 | 
| Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors |  | Day -14 up to approximately Day 126 | 
| Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs |  | Day -14 up to approximately Day 126 | 
| Percentage of NSAID-Prescribers |  | Day -14 up to approximately Day 126 | 
| Percentage of NSAID Self-Medication |  | Day -14 up to approximately Day 126 | 
| Percentage of Participants Using NSAIDs by Disease Activity |  | Day -14 up to approximately Day 126 | 
| Percentage of Participants Using NSAIDs by Disease Duration |  | Day -14 up to approximately Day 126 | 
| Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |  | Day -14 up to approximately Day 126 | 
| HAQ-DI Score |  | Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16 | 
| Disease Activity Score Based on 28 Joints (DAS28) |  | Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16 | 
| Clinical Disease Activity Index (CDAI) Score |  | Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16 | 
| Simplified Disease Activity Index (SDAI) Score |  | Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16 | 
| Percentage of Participants With Adverse Events (AEs) |  | From Baseline up to approximately Week 28 |