Golimumab for Adherence in Rheumatoid Arthritis
GO FAR
2 other identifiers
observational
222
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2023
CompletedJuly 18, 2024
July 1, 2024
4.4 years
November 1, 2018
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Percentage of Adherent Participants at 6 and 12 Months
Months 6 and 12
Number of Participants with Corticosteroid Use
Months 6 and 12
Predicting Factors for Adherence
Months 6 and 12
Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
Months 6 and 12
Percentage of Participants with Response to Patient Support Program Question
Months 6 and 12
Study Arms (1)
Participants with Diagnosis of Rheumatoid Arthritis
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.
Interventions
Participants will receive golimumab as a part of clinical practice.
Eligibility Criteria
All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Inc.lead
Study Sites (32)
Peak Medical Specialty Centre
Calgary, Alberta, T3B 0B2, Canada
Jacqueline C Stewart Medical Inc.
Penticton, British Columbia, V2A 3G7, Canada
Dr. Milton F Baker Inc.
Victoria, British Columbia, V8P 5P6, Canada
Fredericton Medical Clinic
Fredericton, New Brunswick, E3B 6H5, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
St Clare's Hospital
St. John's, Newfoundland and Labrador, A1C 2E9, Canada
Private Practice - Dr. Diane Wilson
Lunenburg, Nova Scotia, B0J2C0, Canada
The Waterside Clinic
Barrie, Ontario, L4M 6L2, Canada
Dr. Sankalp V. Bhavsar Medicine Professional Corporation
Burlington, Ontario, L7R 2H3, Canada
Private Practice - Dr. Pauline Boulos
Dundas, Ontario, L9H 1B7, Canada
Dr. Sangeetha Thiviyarajah Medicine Professional Corporation
Etobicoke, Ontario, M9V 3Z7, Canada
Samuel Silverberg Medicine Professional Corporation
Etobicoke, Ontario, M9V 5G5, Canada
Adachi Medicine Professional Corporation
Hamilton, Ontario, L8N 1Y2, Canada
Manisha Mulgund Medicine Professional Corporation
Hamilton, Ontario, L9C 5N2, Canada
K-W Musculoskeletal Research Inc
Kitchener, Ontario, N2M 5N6, Canada
Markham Rheumatology Hub
Markham, Ontario, L3R 2C7, Canada
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8, Canada
Dr. Rajwinder S Dhillon Medicine Professional Corporation
Niagara Falls, Ontario, L2E 6A6, Canada
Makhzoum Medicine Professional Coporation
Oakville, Ontario, L6H 3P1, Canada
Dr. S. Gill Medicine Professional Corporation
Oakville, Ontario, L6M 1M1, Canada
Dr. Abraham Chaiton Medicine Professional Corporation
Toronto, Ontario, M3N 2V6, Canada
Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Arthur Karasik Medicine Professional Corporation
Toronto, Ontario, M6C 1Y8, Canada
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Clinique de Rhumatologie de Montreal
Montreal, Quebec, H4N 1C6, Canada
Private Practice Dr Louis Bessette
Québec, Quebec, G1V 3M7, Canada
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
Rimouski, Quebec, G5L 5T1, Canada
CIUSSS de L Estrie CHUS
Sherbrooke, Quebec, J1G 2E8, Canada
Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke
Sherbrooke, Quebec, J1J 2E3, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G8Z1Y2, Canada
Community Rheumatology Care
Saskatoon, Saskatchewan, S7K 0H6, Canada
Rheumatology Associates of Saskatoon
Saskatoon, Saskatchewan, S7K 0H6, Canada
Related Publications (1)
Bessette L, Boulos P, Arendse R, Rahman P, Aseer S, Ruban T, Rachich M, Nantel F, Calce A, Asin-Milan O, Haaland D. Impact of Adherence to Golimumab on Disease Flares in Rheumatoid Arthritis: Results from a Canadian Observational Study. Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025.
PMID: 40585577DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Inc. Clinical Trial
Janssen Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 2, 2018
Study Start
January 15, 2019
Primary Completion
June 19, 2023
Study Completion
June 19, 2023
Last Updated
July 18, 2024
Record last verified: 2024-07