Golimumab for Adherence in Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Biological: Golimumab
- Registration Number
- NCT03729349
- Lead Sponsor
- Janssen Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Diagnosis of Rheumatoid Arthritis Golimumab 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Predicting Factors for Adherence Months 6 and 12 Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis.
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.
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.
Trial Locations
- Locations (32)
Dr. Abraham Chaiton Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
K-W Musculoskeletal Research Inc
🇨🇦Kitchener, Ontario, Canada
Dr. Rajwinder S Dhillon Medicine Professional Corporation
🇨🇦Niagara Falls, Ontario, Canada
Dr. Sabeen Anwar Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Makhzoum Medicine Professional Coporation
🇨🇦Oakville, Ontario, Canada
Private Practice Dr Louis Bessette
🇨🇦Quebec, Canada
Markham Rheumatology Hub
🇨🇦Markham, Ontario, Canada
Samuel Silverberg Medicine Professional Corporation
🇨🇦Etobicoke, Ontario, Canada
Dr. Sangeetha Thiviyarajah Medicine Professional Corporation
🇨🇦Etobicoke, Ontario, Canada
The Waterside Clinic
🇨🇦Barrie, Ontario, Canada
Adachi Medicine Professional Corporation
🇨🇦Hamilton, Ontario, Canada
Private Practice - Dr. Pauline Boulos
🇨🇦Dundas, Ontario, Canada
Manisha Mulgund Medicine Professional Corporation
🇨🇦Hamilton, Ontario, Canada
Credit Valley Rheumatology
🇨🇦Mississauga, Ontario, Canada
Dr. S. Gill Medicine Professional Corporation
🇨🇦Oakville, Ontario, Canada
CIUSSS de L Estrie CHUS
🇨🇦Sherbrooke, Quebec, Canada
Dr. Milton F Baker Inc.
🇨🇦Victoria, British Columbia, Canada
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
🇨🇦Rimouski, Quebec, Canada
Clinique de Rhumatologie de Montreal
🇨🇦Montreal, Quebec, Canada
Jacqueline C Stewart Medical Inc.
🇨🇦Penticton, British Columbia, Canada
Peak Medical Specialty Centre
🇨🇦Calgary, Alberta, Canada
Fredericton Medical Clinic
🇨🇦Fredericton, New Brunswick, Canada
Nexus Clinical Research
🇨🇦St. John's, Newfoundland and Labrador, Canada
Private Practice - Dr. Diane Wilson
🇨🇦Lunenburg, Nova Scotia, Canada
Arthur Karasik Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Community Rheumatology Care
🇨🇦Saskatoon, Saskatchewan, Canada
Rheumatology Associates of Saskatoon
🇨🇦Saskatoon, Saskatchewan, Canada
St Clare's Hospital
🇨🇦St. John's, Newfoundland and Labrador, Canada
Dr. Sankalp V. Bhavsar Medicine Professional Corporation
🇨🇦Burlington, Ontario, Canada
Centre de Recherche Musculo Squelettique
🇨🇦Trois Rivieres, Quebec, Canada