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.
Study Type
OBSERVATIONAL
Enrollment
222
Participants will receive golimumab as a part of clinical practice.
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.
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Peak Medical Specialty Centre
Calgary, Alberta, Canada
Jacqueline C Stewart Medical Inc.
Penticton, British Columbia, Canada
Dr. Milton F Baker Inc.
Victoria, British Columbia, Canada
Fredericton Medical Clinic
Fredericton, New Brunswick, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada
St Clare's Hospital
St. John's, Newfoundland and Labrador, Canada
Private Practice - Dr. Diane Wilson
Lunenburg, Nova Scotia, Canada
The Waterside Clinic
Barrie, Ontario, Canada
Dr. Sankalp V. Bhavsar Medicine Professional Corporation
Burlington, Ontario, Canada
Private Practice - Dr. Pauline Boulos
Dundas, Ontario, Canada
...and 22 more locations
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