Arthritis, Rheumatoid
Conditions
Brief summary
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.
Interventions
BIOLOGICALGolimumab
Participants will receive golimumab as a part of clinical practice.
Sponsors
Janssen Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month | 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. |
| Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predicting Factors for Adherence | Months 6 and 12 | Independent predictors of predicted compliance will be assessed with univariate and multivariate Cox regression analysis. |
| Percentage of Adherent Participants at 6 and 12 Months | Months 6 and 12 | Percentage of adherent participants at 6 and 12 Months will be assessed. |
| Percentage of Participants with Response to Patient Support Program Question | Months 6 and 12 | 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. |
| Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab | Months 6 and 12 | 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. |
| Number of Participants with Corticosteroid Use | Months 6 and 12 | 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. |
Countries
Canada
Outcome results
None listed