This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.

Official Title
-----------------
Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Inflectra
* Drug: Inflectra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have been diagnosed with RA by a rheumatologist Have initiated treatment with Inflectra Had assessment of effectiveness in patients who have at least one follow up visit. Exclusion Criteria: No additional exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| characteristics of patients newly initiated on Inflectra<br> | Drug: Inflectra<br>* 1. To describe the characteristics of patients newly initiated on Inflectra.<br>|
| outcomes after initiating Inflectra<br> | Drug: Inflectra<br>* 2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving Low Disease Activity (LDA) | Response is defined as the achievement of LDA (CDAI≤10) among patients with moderate or high disease activity (CDAI>10). CDAI = Clinical Disease Activity Index (Physician Global + Patient Global + tender joint count (TJC) + swollen joint count (SJC)) | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving clinical remission | Clinical remission is defined as CDAI ≤ 2.8 Rate of response at follow up visit-achievement of remission (CDAI≤2.8) among patients with LDA, moderate, or high disease activity (CDAI>2.8) at baseline. | Baseline to 6 months | 
| Change in Clinical Disease Activity Index (CDAI) | Numerical change in CDAI from baseline. Increase in number signifies worsening, decrease in number signifies improvement | Baseline to 6 months | 
| Change in Health Assessment Questionnaire (HAQ) | Numerical change in HAQ (0-3) | Baseline to 6 months | 
| Change in patient pain | Numerical change in patient pain Visual Analogue Scale (VAS) (0-100) | Baseline to 6 months | 
| Change in patient fatigue | Numerical change in patient fatigue Visual Analogue Scale (VAS) (0-100) | Baseline to 6 months | 
| Achievement of mACR20 | Achievement of mACR20 response at 6 months mACR20= Modified American College of Rheumatology 20 response is defined as an improvement of 20% or more from baseline in the number of tender joints (from an analysis of 68 joints), in the number of swollen joints (from an analysis of 66 joints), and in three of the following four domains: a patient's global assessment of arthritis activity, a physician's global assessment of arthritis activity, and a patient's assessment of arthritis pain (with all three evaluations measured on a visual-analogue scale of 0 to 100 mm, with higher scores indicating greater pain or disability); disability as measured by the HAQ-DI | Baseline to 6 months | 
| Achievement of mACR50 | Achievement of mACR50 response | Baseline to 6 months | 
| Achievement of mACR70 | Achievement of mACR70 response | Baseline to 6 months |