Golimumab for Adherence in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— GO FAR  

Official title:

Golimumab for Adherence in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729349
• Other study ID #: CR108555
• Secondary ID: CNTO148ARA4010
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: June 19, 2023

Study information

• Verified date: August 2023
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 19, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Biological:
• Golimumab
Participants will receive golimumab as a part of clinical practice.

Locations

Country	Name	City	State
Canada	The Waterside Clinic	Barrie	Ontario
Canada	Dr. Sankalp V. Bhavsar Medicine Professional Corporation	Burlington	Ontario
Canada	Peak Medical Specialty Centre	Calgary	Alberta
Canada	Private Practice - Dr. Pauline Boulos	Dundas	Ontario
Canada	Dr. Sangeetha Thiviyarajah Medicine Professional Corporation	Etobicoke	Ontario
Canada	Samuel Silverberg Medicine Professional Corporation	Etobicoke	Ontario
Canada	Fredericton Medical Clinic	Fredericton	New Brunswick
Canada	Adachi Medicine Professional Corporation	Hamilton	Ontario
Canada	Manisha Mulgund Medicine Professional Corporation	Hamilton	Ontario
Canada	K-W Musculoskeletal Research Inc	Kitchener	Ontario
Canada	Private Practice - Dr. Diane Wilson	Lunenburg	Nova Scotia
Canada	Markham Rheumatology Hub	Markham	Ontario
Canada	Credit Valley Rheumatology	Mississauga	Ontario
Canada	Clinique de Rhumatologie de Montreal	Montreal	Quebec
Canada	Dr. Rajwinder S Dhillon Medicine Professional Corporation	Niagara Falls	Ontario
Canada	Dr. S. Gill Medicine Professional Corporation	Oakville	Ontario
Canada	Makhzoum Medicine Professional Coporation	Oakville	Ontario
Canada	Jacqueline C Stewart Medical Inc.	Penticton	British Columbia
Canada	Private Practice - Dr. Louis Bessette	Quebec
Canada	Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski	Rimouski
Canada	Community Rheumatology Care	Saskatoon	Saskatchewan
Canada	Rheumatology Associates of Saskatoon	Saskatoon	Saskatchewan
Canada	CIUSSS de L'Estrie - CHUS	Sherbrooke	Quebec
Canada	Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke	Sherbrooke
Canada	Nexus Clinical Research	St. John's	Newfoundland and Labrador
Canada	St. Clare's Hospital	St. John's	NFLD
Canada	Arthur Karasik Medicine Professional Corporation	Toronto	Ontario
Canada	Dr. Abraham Chaiton Medicine Professional Corporation	Toronto	Ontario
Canada	Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Centre de Recherche Musculo Squelettique	Trois Rivieres	Quebec
Canada	Dr. Milton F Baker Inc.	Victoria	British Columbia
Canada	Dr. Sabeen Anwar Medicine Professional Corporation	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Adherent Participants at 6 and 12 Months	Percentage of adherent participants at 6 and 12 Months will be assessed.	Months 6 and 12
Secondary	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.	Months 6 and 12
Secondary	Predicting Factors for Adherence	Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis.	Months 6 and 12
Secondary	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.	Months 6 and 12
Secondary	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.	Months 6 and 12