Golimumab for Adherence in Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.

Official Title
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Golimumab for Adherence in Rheumatoid Arthritis

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Biological: Golimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a confirmed diagnosis of rheumatoid arthritis About to initiate therapy with golimumab Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Exclusion Criteria: Diagnosis of Axial Spondyloarthritis, Ankylosing Spondylitis or Psoriatic Arthritis Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point Currently enrolled in an investigational study Currently enrolled in an observational study sponsored or managed by a Janssen company

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 Diagnosis of Rheumatoid Arthritis<br>Participants will not receive any intervention as a part of this study. All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed. | Biological: Golimumab<br>* Participants will receive golimumab as a part of clinical practice.<br>* Other names: SIMPONI ™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month | Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 6 month in participants categorized as low predicted compliance vs high predicted compliance. RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome. | 6 Month | 
| Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month | Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 12 month in participants categorized as low predicted compliance vs high predicted compliance. RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome. | 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Adherent Participants at 6 and 12 Months | Percentage of adherent participants at 6 and 12 Months will be assessed. | Months 6 and 12 | 
| Number of Participants with Corticosteroid Use | Number of participants with corticosteroid use will be assessed among participants categorized as low predicted compliance vs high predicted compliance at 6 and 12 months. | Months 6 and 12 | 
| Predicting Factors for Adherence | Independent predictors of predicted compliance will be assessed with univariate and multivariate Cox regression analysis. | Months 6 and 12 | 
| Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab | Number of participants with any AEs, SAEs or discontinuation of golimumab will be assessed among participants categorized as low predicted compliance vs high predicted compliance at 6 and 12 months and include any such event up to the previous study visit. | Months 6 and 12 | 
| Percentage of Participants with Response to Patient Support Program Question | Percentage of participants with response to Patient Support Program Question (Yes/No) will be assessed among participants categorized as low predicted compliance vs high predicted compliance at 6 and 12 months. | Months 6 and 12 |