An observational study in Arthritis, Rheumatoid, sponsored by Janssen Inc.. Completed at 32 sites in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Janssen Inc. · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 222 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Janssen Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
Exclusion Criteria:
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
Participants will receive golimumab as a part of clinical practice.
Also known as: SIMPONI ™
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.
Time frame: 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.
Time frame: 12 Month
Percentage of Adherent Participants at 6 and 12 Months
Percentage of adherent participants at 6 and 12 Months will be assessed.
Time frame: 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.
Time frame: Months 6 and 12
Predicting Factors for Adherence
Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis.
Time frame: 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.
Time frame: 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.
Time frame: Months 6 and 12
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Janssen Inc.